BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 10348344 · Received July 30, 2020

    Report

    Report Number
    1911916-2020-00703
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 7/23/2020. H.6. INVESTIGATION: TWO PHOTOS AND SIX 1ML LL SYRINGES WERE RECEIVED. FOUR OF THE SYRINGES WERE IN OPENED BLISTER PACKS (P/N 309628). TWO WERE FROM BATCH 9294259 AND TWO WERE FROM BATCH 9294272. THE PHOTOS DEPICTED TWO LOOSE 1ML LL SYRINGES FILLED WITH UNKNOWN CLEAR LIQUID AND A CUSTOMER LABEL ATTACHED. IN THE PHYSICAL SAMPLES, IT APPEARED THE "HAIRLINE CRACK" IS A SMALL AMOUNT OF EXCESS MATERIAL, WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE FLASHING DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DHR'S WERE PERFORMED FOR THE LOT #'S. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL W/O DN WAS DEFORMED BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FINE HAIR LINE CRACKS HAVE BEEN OBSERVED ON THE BARREL 1ML BD SYRINGES."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9232822, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-10-03, MEDICAL DEVICE LOT #: 9294259, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-12-05, MEDICAL DEVICE LOT #: 9294272, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-12-05. 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 1ML LL W/O DN WAS DEFORMED BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FINE HAIR LINE CRACKS HAVE BEEN OBSERVED ON THE BARREL 1ML BD SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812653 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309628 SEE H.10. 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other