BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11248732 · Received January 28, 2021

    Report

    Report Number
    1213809-2021-00045
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL?: YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: D.10. RETURNED TO MANUFACTURER ON: 1/22/2021. H.6. INVESTIGATION: ONE 3ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 0161865 (P/N 309657) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS TWO LENGTHWISE CRACKS PRESENT IN THE BARREL. ONE WAS INSIDE THE GRAD LINES AND EXTENDED FROM THE 0.5ML TO THE 1.5ML MARKING. ONE WAS OUTSIDE THE GRAD LINES AND EXTENDED FROM THE 0.5ML TO THE 1.2ML MARKING. THE CRACKED BARREL WAS REJECTABLE PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 0161865. IT WAS REPORTED THAT WHEN SYRINGE LEAKED FROM SIDE OF THE BARREL NEAR THE 1ML MARKING WHEN DRAWING UP SERUM. COMPLAINT DETAILS PER PHONE CALL: CUSTOMER CALLED TO REPORT THAT WHEN DRAWING UP SERUM, SYRINGE LEAKED OUT FROM THE SIDE OF THE BARREL BY THE 1ML MARKING.

    Additional Manufacturer Narrative · 1

    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 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: 0161865. IT WAS REPORTED THAT WHEN SYRINGE LEAKED FROM SIDE OF THE BARREL NEAR THE 1ML MARKING WHEN DRAWING UP SERUM. COMPLAINT DETAILS PER PHONE CALL: CUSTOMER CALLED TO REPORT THAT WHEN DRAWING UP SERUM, SYRINGE LEAKED OUT FROM THE SIDE OF THE BARREL BY THE 1ML MARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145045 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0161865 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1