BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE XS

    MDR report key: 8600877 · Received May 10, 2019

    Report

    Report Number
    9616657-2019-00206
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE SAMPLES RECEIVED AS PART OF THIS COMPLAINT CONFIRMS BAD PERFORATION. A DEVICE HISTORY WAS ALSO CONDUCTED, WHICH SHOWED NO NON-CONFORMANCE'S. THE ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED WITH THE PERFORATION STAGE OF THE MANUFACTURING PROCESS. THE BLADE MAINTENANCE PROGRAM IS CURRENTLY UNDER REVIEW. THE INTENTION IS TO DECREASE THE TIME FRAME BETWEEN BLADE REPLACEMENTS, THEREFORE PREVENTING POOR PERFORATION IN THE BLISTER PACKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML SALINE XS EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IN THE LAST 2 MONTHS MASSIVE PROBLEMS WITH THE SYRINGE. THERE WERE 167 PIECES SORTED OUT DUE TO BAD PERFORATION ( ONE HAD TO PARTIALLY WORK WITH THE SCISSORS!) AND THEY WERE ALSO PARTIALLY DIRTY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9080916 ; MEDICAL DEVICE EXPIRATION DATE: 2022-02-28; DEVICE MANUFACTURE DATE: 2019-03-21; MEDICAL DEVICE LOT #: 9074905; MEDICAL DEVICE EXPIRATION DATE: 2022-02-28; DEVICE MANUFACTURE DATE: 2019-03-15.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML SALINE XS EXPERIENCED POOR PERFORATION ON PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IN THE LAST 2 MONTHS MASSIVE PROBLEMS WITH THE SYRINGE. THERE WERE 167 PIECES SORTED OUT DUE TO BAD PERFORATION (ONE HAD TO PARTIALLY WORK WITH THE SCISSORS!) AND THEY WERE ALSO PARTIALLY DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391468 SYRINGE 10ML SALINE XS SYRINGE FMF BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other