BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LL BNS

    MDR report key: 8475695 · Received April 2, 2019

    Report

    Report Number
    1213809-2019-00405
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 12, 2019
    Report Date
    May 6, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B.3. DATE OF EVENT: (B)(6) 2019. D.4. MEDICAL DEVICE LOT #: 9030991. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. H.4. DEVICE MANUFACTURE DATE: 2019-01-30.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS AND 16 LOOSE 10ML SYRINGES WERE RECEIVED AND VISUALLY EVALUATED. THE STOPPERS AND ROOFS OF THE BARRELS WERE FOUND TO HAVE SMALL AMOUNTS OF SILICONE RESIDUE. THE AMOUNT OBSERVED WAS A NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION IN ALL OF THE 16 SAMPLES INSPECTED. THE PHOTOS DEPICTED LOOSE PLUNGER RODS. SILICONE RESIDUE WAS VISIBLE ON THE STOPPERS. THE AMOUNT OF SILICONE APPEARED NORMAL, THOUGH STOPPERS WERE NOT VERY WELL ILLUMINATED FOR A THOROUGH EVALUATION. DURING DHR REVIEW ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. A QUALITY NOTIFICATION WAS ISSUED FOR EXCESS SILICONE DUE TO ASSEMBLY ISSUES. ADJUSTMENTS WERE MADE AND PRODUCT REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 9030991 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE LL BNS HAD SOME SORT OF OILY ON THE TOP OF STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ WE HAVE NOTICED THAT FOR THIS PRODUCT (NON-STERILE LUER-LOK SYRINGES) THE PLUNGER WITH THE RUBBER TIP HAS SOME SORT OF OILY SUBSTANCE ALMOST LIKE SOME SORT OF LUBRICANT. ¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE LL BNS HAD SOME SORT OF OILY ON THE TOP OF STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ WE HAVE NOTICED THAT FOR THIS PRODUCT (NON-STERILE LUER-LOK SYRINGES) THE PLUNGER WITH THE RUBBER TIP HAS SOME SORT OF OILY SUBSTANCE ALMOST LIKE SOME SORT OF LUBRICANT. ¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE LL BNS HAD SOME SORT OF OILY ON THE TOP OF STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WE HAVE NOTICED THAT FOR THIS PRODUCT (NON-STERILE LUER-LOK SYRINGES) THE PLUNGER WITH THE RUBBER TIP HAS SOME SORT OF OILY SUBSTANCE ALMOST LIKE SOME SORT OF LUBRICANT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269661 BD SYRINGE LL BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9030991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other