BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9187071 · Received October 14, 2019

    Report

    Report Number
    1213809-2019-01035
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 27, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE OPENED SHELF CARTON WAS RECEIVED, CONTAINING APPROXIMATELY 200 SEALED PACKAGED 3ML SYRINGES, CONFIRMED TO BE FROM BATCH #9130794 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. ALL OF THE SAMPLES WERE IDENTIFIED TO HAVE MISSING PRINT DEFECT WITH VARYING DEGREE OF PRINT MISSING. FEW SYRINGES HAD MOST OF THE SCALE MARKINGS PRESENT WITH ONLY BD LOGO TO 3ML MARKINGS SMUDGED OR MISSING. MOST SYRINGES HAD MOST OF THE SCALE MARKINGS MISSING WITH ONLY PORTIONS OF THE PRINT PRESENT NEAR THE ZERO LINE AND AN OCCASIONAL INK RING. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS AND WITH FAILURE TO CONTAIN DEFECT. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. A QUALITY NOTIFICATION WAS ISSUED FOR MISSING PRINT DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE, LINE CLEARED AND PRODUCT REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 9130794 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 AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED MISSING SCALE MARKINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9130794. WE GOT AN ORDER OF 309657 3ML SYRINGES. LOT NUMBER 9130794 THE ISSUE THAT WE HAD IS THAT THERE WAS NO MEASUREMENTS ON THEM THEY ARE ALL JUST CLEAR SYRINGES. I HAVE LOOKED THROUGH OUR STOCK AND THE REST LOOK GOOD BUT HAVEN¿T OPENED UP ANY OTHER CASES BUT THEY ARE A DIFFERENT LOT NUMBER.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED MISSING SCALE MARKINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9130794. WE GOT AN ORDER OF 309657 3ML SYRINGES. LOT NUMBER 9130794: THE ISSUE THAT WE HAD IS THAT THERE WAS NO MEASUREMENTS ON THEM THEY ARE ALL JUST CLEAR SYRINGES. I HAVE LOOKED THROUGH OUR STOCK AND THE REST LOOK GOOD BUT HAVEN¿T OPENED UP ANY OTHER CASES BUT THEY ARE A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983532 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9130794 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other