Sex: U
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: defect discovered during preparation, administration, mixing was performed gently from side to side, vial was held upside-down when withdrawn; some of the Hiberix PFS luer lock syringe hubs are not attached to the syringe; product complaint; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong technique in device usage process in a patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong technique in device usage process (Verbatim: defect discovered during preparation, administration, mixing was performed gently from side to side, vial was held upside-down when withdrawn), syringe connection issue (Verbatim: some of the Hiberix PFS luer lock syringe hubs are not attached to the syringe) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the wrong technique in device usage process, syringe connection issue and pharmaceutical product complaint were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 28-MAY-2024 The reporter was the HCP (Healthcare professional) registered nurse, and she was experienced vaccinator. She reported that some of the Hiberix PFS luer lock syringe hubs were not attached to the syringe. This defect was discovered during preparation and administration. The vaccines were administered. The mixing was performed gently from side to side. The vial was held upside-down when withdrawn. All of the defective syringes were discarded after use, which led to, wrong technique in device usage process and Syringe connection issue. No pictures were taken. The reporter did not know how many syringes were defective all were the same batch number. Some boxes with this lot were intact (the luer lock syringe hub was secure to the tip of the syringe and the needle fits securely). Other boxes of this lot had loose luer locks. The reporter mentioned in one case, after administration to the patient, the needle/luer lock tip fell off the syringe when the safety mechanism on the needle was engaged. The reporter estimates about 7 or 8 syringes in some of the boxes (same lot) were affected. She did not know the number of boxes total. The office was now checking all the syringe tips prior to use and if the luer lock syringe hub was loose, another syringe was used to draw up the reconstituted vaccine, which led to, wrong technique in device usage process. The luer lock hub part of the syringe was loose. The luer lock on syringe was not connected to the syringe it was loose. The detachment happened during use. There were no liquid and dried liquid traces found in the blister.  There was no visible damage, but it was not attached to the syringe tip itself. The luer lock safety needle was attached gently. The rotating luer lock adaptor that was detached from the syringe. There was no needle available which was used, all needle discarded because they were used to administer vaccine to patient. There was no damage/breakage on the syringe barrel. The quantity affected line was left blank because the reporter did not know how many syringes were affected. The reporter consented to the follow up.