BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 10143894 · Received June 11, 2020

    Report

    Report Number
    1213809-2020-00388
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FORTY-EIGHT 3ML SYRINGES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH 9130794 (P/N 309657). THE SAMPLES WERE VISUALLY EVALUATED. ALL 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. ALL FORTY-EIGHT SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. A QUALITY NOTIFICATION WAS ISSUED FOR SMEARED PRINT. BATCH 9140840 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS AND WITH FAILURE TO CONTAIN DEFECT. MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THE BATCH AND ADJUSTMENTS WERE MADE TO ADDRESS THE ISSUE. ACTIONS WERE TAKEN TO CONTAIN THE DEFECT, INCLUDING FULL CLEARING OF THE MANUFACTURING LINE AND REQUALIFICATION OF PACKAGED PRODUCT PER APPLICABLE AQL. CAPA 753644 WAS IMPLEMENTED SEPTEMBER 2019 TO PERFORM TIGHTER INSPECTIONS DURING A REQUALIFICATION FOR PRINT RELATED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 SYRINGES 3ML LL 200 S/C HAD ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE GRADUATED MARKINGS ARE EITHER SMUDGED OR MISSING. PER PHONE CALL: CUSTOMER CALLED AND REPORTED "AFTER THE 1 1/2ML GRADUATION MARKS THE OTHER MARKS ARE EITHER SMUDGED OR MISSING MAKING IT DIFFICULT TO MEASURE ACCURATELY. "THEY HAVE A 100 PIECES OF THIS SYRINGES FROM LOT 9130794, REF 309657. CUSTOMER IS REQUESTING REPLACEMENT 1 CASE. SAMPLES ARE AVAILABLE FOR RETURN."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 100 SYRINGES 3ML LL 200 S/C HAD ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE GRADUATED MARKINGS ARE EITHER SMUDGED OR MISSING." PER PHONE CALL: CUSTOMER CALLED AND REPORTED "AFTER THE 1 1/2ML GRADUATION MARKS THE OTHER MARKS ARE EITHER SMUDGED OR MISSING MAKING IT DIFFICULT TO MEASURE ACCURATELY. " THEY HAVE A 100 PIECES OF THIS SYRINGES FROM LOT 9130794, REF (B)(4). CUSTOMER IS REQUESTING REPLACEMENT 1 CASE. SAMPLES ARE AVAILABLE FOR RETURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610040 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 9130794 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other