BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 9246135 · Received October 28, 2019

    Report

    Report Number
    1911916-2019-01122
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 13, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: APPROXIMATELY THREE HUNDRED THIRTY (330) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION IN SEALED BLISTER PACKS. THE RETURNED SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION. IT WAS OBSERVED THAT TEN (10) OF THE RETURNED SAMPLES HAD DAMAGE. THE DAMAGE TO THE SIDE WALL OF THE SYRINGE BARREL WAS IN THE FORM OF EITHER A NICK OR GASHES IN THE SIDE OF THE BARREL. THESE NICKS OR GASHES ARE CONSISTENT WITH A HARD EDGE BEING FORCIBLY SMASHED INTO THE SIDE OF THE BARREL AND WERE FOUND TO BE AT SIMILAR LOCATIONS ON THE BARREL. HOWEVER, THESE NICKS OR GASHES DO NOT PENETRATE THROUGH THE SIDE OF THE BARREL. BASED ON THE DAMAGED OBSERVED IT APPEARS THAT THE BARRELS WERE CONTACTED BY A HARD EDGE AFTER ASSEMBLY AND BEFORE PACKAGING WHICH RESULTED IN THE BARRELS BEING DAMAGED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 309653, BATCH NO. 9120855, 9120895. IT WAS REPORTED THAT BEFORE USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH PRODUCT DAMAGE. THE "SYRINGES WERE BEAT UP WITHIN THE PACKAGING". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, PACKAGE IS FINE BUT SYRINGES ARE BEAT UP WITHIN PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9120855. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-30. MEDICAL DEVICE LOT #: 9120895. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-30. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 309653, BATCH NO. 9120855, 9120895. IT WAS REPORTED THAT BEFORE USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH PRODUCT DAMAGE. THE "SYRINGES WERE BEAT UP WITHIN THE PACKAGING". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER, PACKAGE IS FINE BUT SYRINGES ARE BEAT UP WITHIN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042536 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other