Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product administration error, Product physical issue, Syringe issue
Clinical narrative: No aditional AE information provided; The MA moved her two fingers up against the finger flanges one bore and a piece of glass fell onto the floor; The MA moved her two fingers up against the finger flanges one bore and a piece of glass fell onto the floor. he syringe was immediately removed from the patient and not administered; is there a crack? YES: A piece is missing from the finger flange approx a quarter of the diameter. Crack on the finger flange; This spontaneous report was received from an officer manager and refers to a patient of unknown age and gender.  The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.    On 27-APR-2021, the patient was going to vaccinate with a pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe, lot # 1659422, expiration date 04-SEP-2022, 0.5 milliliter (route not reported) for prophylaxis. The needle was inserted into the patient, but when the medical assistant moved her two fingers up against the finger flanges one broke and a piece of glass fell onto the floor. The syringe was immediately removed from the patient and not administered. The patient was administered another pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe, 0.5 ml (lot #, expiration date and route were not reported) for prophylaxis . The office manager had on hold the syringe for retrieval and she verified there was no blood or other bodily fluids on the syringe and the needle has been removed.   The syringe was not broken in the tray or when the needle was attached. There was a crack on the finger flange. A piece was missing from the finger flange approximately a quarter of the diameter. The syringe was not broken into 2 pieces. The syringe tip cap was attached properly prior to use. The syringe tray was intact and undamaged on receipt. The cellophane was covering the syringe tray intact and completely sealed. The syringe carton was not damaged prior to use.  This a non-valid report due to lack of patient identifiers.  Follow-up information was received from Merck Manufacturing Division (MMD) on 04-AUG-2021. This PQC record has been re-opened based on new information related to a potential harm associated with broken syringe during and after injection. The device problem and evaluation codes were updated. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Yes; productavailableforevaluation: Returned to Manufacturer; productreturndate: 30-APR-2021; deviceusage: Initial; evaluatedbymfr: Yes; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: Yes; mdcpreprationale: Refer to QCC4 record for reportability rationale; evaluationvalue - Patient / Device: N/A / 2978; N/A / 1069 evaluationvalue - Method / Result / Conclusion: 4112 / 213 / 4315; 4112 / 213 / 4315; 10 / 213 / 4315; 11 / 213 / 4315