BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10BAG 500CS

    MDR report key: 10731344 · Received October 23, 2020

    Report

    Report Number
    1920898-2020-01471
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 2, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/23/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7352814, (2) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7299608, (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8092786, (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9287751, AND (2) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9266901. NO SAMPLES WERE RETURNED FROM LOT # 8197659. CUSTOMER STATES THAT THE POLY BAG WAS NOT PERFORATED TO ALLOW TO TEAR EASILY; NEEDLE SHIELD DIFFICULT TO REMOVE; NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD; PLUNGER ROD BROKE OFF; BARREL WAS CRACKED; NEEDLE WAS BENT. THE SAMPLE FROM LOT # 7352814 WAS TESTED TO DETERMINE THE SHIELD REMOVAL FORCE. THE SHIELD REMOVAL FORCE WAS MEASURED AS 2.95 LBS., WHICH FALLS WITHIN SPECIFICATIONS. THE SAMPLES FROM LOT # 7299608 WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. THE SAMPLE FROM LOT # 8092786 WAS EXAMINED AND EXHIBITED A BROKEN PLUNGER ROD. THE SAMPLE FROM LOT # 9287751 WAS EXAMINED AND EXHIBITED A CRACKED AND DAMAGED BARREL. THE SAMPLES FROM LOT # 9266901 WERE EXAMINED AND ONE SAMPLE EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL WHILE THE OTHER SYRINGE EXHIBITED A BENT CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7299608. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SIX (6) NOTIFICATIONS [200725218, 200725389, 200724965, 200725126, 200725185, 200725025] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8092786. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9287751. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE EIGHT (8) NOTIFICATIONS [200854096, 200854085, 200850786, 200850775, 200854094, 200850966, 200850884, 200850779] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200850634] NOTED FOR DAMAGED TIPS A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9266901. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOR LOT # 7299608, 8092786, 9287751, 9266901). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOR LOT # 8197659 AND LOT # 7352814). PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. HUB SEPARATES (LOT #7299608): DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. BROKEN THUMB PRESS (LOT #8092786): ROOT CAUSE: THE PLUNGERS WERE NOT GOING ON THE MAIN DIAL. HUB SEPARATES (LOT #9266901): DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. BENT CANNULA (LOT #9266901): DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CRACKED BARREL (LOT #9287751): ROOT CAUSE: THE AIR JET WAS OUT OF ADJUSTMENT. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10BAG 500CS NEEDLE HUB SEPARATED, THE BARREL WAS CRACKED, AND THE PRODUCT WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 8197659, 7352814, 7299608, 8092786, 9287751, 9266901. IT WAS REPORTED THAT THE POLY BAG WAS NOT PERFORATED TO ALLOW TO TEAR EASILY; NEEDLE SHIELD DIFFICULT TO REMOVE; NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD; PLUNGER ROD BROKE OFF; BARREL WAS CRACKED; NEEDLE WAS BENT. LOT #: 8197659 - POLY BAG NOT PERFORATED TO ALLOW EASY TEAR. LOT #: 7352814 - NEEDLE SHIELD DIFFICULT TO REMOVE. LOT #: 7299608 - NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD - DOES NOT REMEMBER IF SHIELD WAS DIFFICULT TO REMOVE. LOT #: 8092786 - PLUNGER ROD BROKE OFF. LOT #: 9287751 - BARREL CRACKED AT THE TOP, NEAR THE PLUNGER (DESCRIBED AS KNIFE CUTS IN THE BARREL). LOT #: 9266901 - NEEDLE BENT (CROOKED), NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8197659; MEDICAL DEVICE EXPIRATION DATE: 2023-07-31; DEVICE MANUFACTURE DATE: 2018-07-16. MEDICAL DEVICE LOT #: 7352814; MEDICAL DEVICE EXPIRATION DATE: 2022-12-31; DEVICE MANUFACTURE DATE: 2017-12-18. MEDICAL DEVICE LOT #: 7299608; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 8092786; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-04-02. MEDICAL DEVICE LOT #: 9287751; MEDICAL DEVICE EXPIRATION DATE: 2024-10-31; DEVICE MANUFACTURE DATE: 2019-10-14. MEDICAL DEVICE LOT #: 9266901; MEDICAL DEVICE EXPIRATION DATE: 2024-10-31; DEVICE MANUFACTURE DATE: 2019-09-23. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 6MM 10BAG 500CS NEEDLE HUB SEPARATED, THE BARREL WAS CRACKED, AND THE PRODUCT WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911; BATCH NO: 8197659, 7352814, 7299608, 8092786, 9287751, 9266901. IT WAS REPORTED THAT THE POLY BAG WAS NOT PERFORATED TO ALLOW TO TEAR EASILY; NEEDLE SHIELD DIFFICULT TO REMOVE; NEEDLE HUB SEPARATED AND STAYED IN THE SHIELD; PLUNGER ROD BROKE OFF; BARREL WAS CRACKED; NEEDLE WAS BENT. LOT #: 8197659: POLY BAG NOT PERFORATED TO ALLOW EASY TEAR. LOT #: 7352814: NEEDLE SHIELD DIFFICULT TO REMOVE. LOT #: 7299608: NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD - DOES NOT REMEMBER IF SHIELD WAS DIFFICULT TO REMOVE. LOT #: 8092786: PLUNGER ROD BROKE OFF. LOT #: 9287751: BARREL CRACKED AT THE TOP, NEAR THE PLUNGER (DESCRIBED AS KNIFE CUTS IN THE BARREL). LOT #: 9266901: NEEDLE BENT (CROOKED), NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196235 SYRINGE 0.5ML 31GA 6MM 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 SEE H.10 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1