Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Periarthritis, Syringe issue
Clinical narrative: Frozen left shoulder; Limited range of motion and strength; Needle fell off the syringe so the nurse pushed real hard; Limited range of motion and strength; Pain in the left arm; Needle fell off the syringe so the nurse pushed real hard; This is a spontaneous case from the, initially received from other non-health professional to The Agency (reference number: SEQW20-00191) on 20-Mar-2020, concerning a 47-year-old, female patient.  The patient had no medical history.  The patient had no concomitant medications.  On an unspecified date in Oct-2018, the needle fell off the syringe and the nurse pushed real hard to administered to the patient Afluria Quadrivalent [influenza vaccine, route of administration: intramuscular, anatomical location: left deltoid, dose: 0.5 ml (as reported, the full dose was administered), batch number: YF41208 and expiration date: 30-Jun-2019] (explicitly coded as 'Product administration error' and 'Needle issue') for influenza prophylaxis. The device associated with Afluria Quadrivalent was Luer Lok syringe.   On an unspecified date in Oct-2018, unknown amount of time after vaccination, the patient experienced a frozen left shoulder, pain in the left arm and had limited range of motion and strength.  At the time of this report, the pain was improved, but the patient still had limited range of motion and strength. The outcome of 'frozen shoulder' was not resolved.   Product technical complaint (PTC) number 1055541 was assigned to this case.  Based on the Quality Assurance Investigation it was concluded that although a definitive root cause could be not determined as part of this investigation, there was no indication of a systemic manufacturing or syringe raw material defect.  It remains possible that the Luer Lock adaptor may had detached from the syringe as a result of the end user over-torqueing the needle into the attachment prior to administration and caused the Luer Lock to detach. To this, BD has provided a memorandum outlining recommendations for optimal syringe preparation.  This detached Luer Lock was unlikely attributed to a systemic manufacturing defect. On this basis, the final risk rating is 'Low'. Beyond the individual dose, the reported defect presents no residual risk to the remainder of the batch as is now expired and should no longer be available for patient administration. This was the only PTC for lot YF41208 and a detached Luer Lock for the NH 2018 - 2019 Influenza campaign. All material passed required testing against approved specifications for each component and was found to be satisfactory for use. There were no damages noted on the transport.   This case was assessed as non-serious, per reporter.   The reporter did not provide causality assessment to Afluria Quadrivalent.  Follow up information received from other non-health professional to The Agency (reference number: SEQW20-00190) on 20-Mar-2020: Primary reporter information updated. Details about damaged syringe was provided. The narrative was amended accordingly.  Follow up information received from PTC group on 05-May-2020: Quality Assurance Investigation results were provided. The narrative was amended accordingly.   Company comment: The patient developed periarthritis, muscular weakness, injected limb mobility decreased and pain in extremity on an unknown date, reportedly within the same month, after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Reportedly, the needle fell off the syringe and the nurse pushed real hard to administered to the patient Afluria Quadrivalent (explicitly coded as 'Product administration error' and 'Needle issue'). No information regarding medical history and concomitant medication was provided. Product administration error is assessed as not related to Afluria Quadrivalent and device Luer Lok syringe per company conventions, while for all other events as unlikely related due to medication error and needle issue. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes) For needle issue, which is considered as PQC, causality is assessed as related to device Luer Lok syringe and not related to Afluria Quadrivalent per company conventions. Causality for the events of 'painful L arm', 'injected limb mobility decreased', 'muscular weakness upper limb' and 'frozen shoulder' are assesses as related to device Luer Lok syringe.; Sender's Comments: The patient developed periarthritis, muscular weakness, injected limb mobility decreased and pain in extremity on an unknown date, reportedly within the same month, after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Reportedly, the needle fell off the syringe and the nurse pushed real hard to administered to the patient Afluria Quadrivalent (explicitly coded as 'Product administration error' and 'Needle issue'). No information regarding medical history and concomitant medication was provided. Product administration error is assessed as not related to Afluria Quadrivalent and device Luer Lok syringe per company conventions, while for all other events as unlikely related due to medication error and needle issue. (''unlikely related'' defaults to ''related'' in the safety database for reporting purposes) For needle issue, which is considered as PQC, causality is assessed as related to device Luer Lok syringe and not related to Afluria Quadrivalent per company conventions. Causality for the events of 'painful L arm', 'injected limb mobility decreased', 'muscular weakness upper limb' and 'frozen shoulder' are assesses as related to device Luer Lok syringe.