BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 11404982 · Received March 3, 2021

    Report

    Report Number
    1920898-2021-00252
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6:INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1/2CC, 8MM SYRINGES. CUSTOMER STATES THAT THE SYRINGE HUB IS CURVED. THE RETURNED SYRINGES WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON THE RETURNED SAMPLES. THE CUSTOMER ALSO RETURNED A PHOTO WHICH WAS ALSO EXAMINED. THE PHOTO EXHIBITED A SYRINGE WITH A SLIGHTLY TILTED HUB/SHIELD ASSEMBLY, INDICATING THAT THERE MAY BE A SLIGHTLY DEFORMED BARREL TIP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0153021. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200895749] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.ROOT CAUSE:L2L MAINTENANCE DISPATCH #102220 DAMAGED BARREL TIP WAS GENERATED ON 25JUL2020 ON CH PRINTER. CORRECTIVE ACTION:THE INFEED DIAL WAS ADJUSTED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN WERE DAMAGED AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CURVED SYRINGE HUB".

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR HUB DAMAGED (CURVED SYRINGE HUB) ON LOT # 0153021. INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1/2CC, 8MM SYRINGES. CUSTOMER STATES THAT THE SYRINGE HUB IS CURVED. THE RETURNED SYRINGES WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON THE RETURNED SAMPLES. THE CUSTOMER ALSO RETURNED A PHOTO WHICH WAS ALSO EXAMINED. THE PHOTO EXHIBITED A SYRINGE WITH A SLIGHTLY TILTED HUB/SHIELD ASSEMBLY, INDICATING THAT THERE MAY BE A SLIGHTLY DEFORMED BARREL TIP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0153021. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200895749] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED BARREL TIP) ON 25FEB2021, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE, FROM MATERIAL 328468, BATCH 0153021 SYRINGE 0.5ML 30G 8MM. INITIAL EVALUATION: VISUAL INSPECTION OF THE PICTURE SHOWED A SYRINGE WITH A ATTACHED NEEDLE ASSEMBLY UNIT SLIGHTLY TILTED ON THE BARREL INDICATING A DAMAGED BARREL TIP. PROCESS SUMMARY: PROCESS SUMMARY: BLANK BARRELS ARE TRANSFERRED FROM TOTES TO A BULK HOPPER, THE HOPPER THEN TRANSPORTS THEM INTO THE VIBRATORY FEEDER WHICH ORIENTS AND TRANSFERS THE BARRELS SINGLE FILE INTO THE FIRST INLINE FEEDER. THE FIRST INLINE FEEDER RAIL TRANSFERS TO THE INSPECTION DIAL WHERE SHORT MOLDING DEFECTS ARE REJECTED. AFTER THE INSPECTION DIAL, THE BARRELS ARE TRANSFERRED TO THE SECOND INLINE FEEDER AND TRANSITIONS THROUGH THE CORONA TREATER TERMINATING AT THE INHIBIT GATE. AT CYCLE START, THE INHIBIT GATE OPENS, INTRODUCING BARRELS TO PRINTER INFEED DIAL ON THROUGH THE FLANGE GUIDE WHICH ALIGNS THE FLANGES FOR PROPER REGISTRATION AND INTO THE PRINT CAROUSEL WHERE INK IMAGES ARE APPLIED. FROM THE PRINT CAROUSEL, THE BARRELS ARE TRANSITIONED TO THE TRANSFER DIAL AND INTO THE CURING OVEN. THE CURED PRODUCT EXITS THE OVEN CHUTE FOR TRANSFER TO THE NEXT OPERATION. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0153021 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE SYRINGE DEFECT. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: VISUAL INSPECTION EVERY 30 MINUTES: DAMAGED BARREL DEFECTS THAT AFFECT STERILITY BARRIER OR FUNCTIONALITY. VISUAL INSPECTION EVERY 30 MINUTES: DAMAGED BARREL DEFECTS THAT DO NOT AFFECT STERILITY BARRIER OR FUNCTIONALITY. IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED ROOT CAUSE: L2L MAINTENANCE DISPATCH #102220 DAMAGED BARREL TIP WAS GENERATED ON 25JUL2020 ON CH PRINTER. CORRECTIVE ACTION: THE INFEED DIAL WAS ADJUSTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN WERE DAMAGED AT AN UNSPECIFIED TIME. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CURVED SYRINGE HUB".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300843 SYRINGE 0.5ML 31GA 8MM TW 10BAG 500 TWN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0153021

    Patients

    Seq Age Sex Outcome Treatment
    1