BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SLIP TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 14376451 · Received May 12, 2022

    Report

    Report Number
    8041187-2022-00249
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 19-JUL-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1231367. THE PACKAGE OVERCUT COULD HAVE LED TO THE UNIT PACKAGE OPENING WITH PARTIAL SEALING OR WITHOUT SEALING. THE TEAM HAS INVESTIGATED DIFFERENT SECTIONS OF MACHINE AND MATCHED A POTENTIAL AREA WHICH COULD LEAD TO THE REPORTED DEFECTS. THERE ARE PERFORATION KNIVES LOCATED AT THE PRIMARY PACKAGING MACHINE, WHICH ARE USED TO PERFORATE THE PACKED SYRINGE INTO BLISTER UNITS. THE PERFORATION KNIFE HOLDER HOLDS THE PERFORATION KNIFE / BLADE AT THE STATION LOCATION IN ORDER TO ENSURE EVEN BLISTER UNIT CUTS AND FULFILL THE SEALING REQUIREMENTS. IT WAS REPORTED THAT THE PRODUCTION TECHNICIAN DETECTED PERFORATION OVERCUT DURING THE PRODUCTION RUN. THE ROOT CAUSE IS DUE TO THE PERFORATION HOLDER SCREW WEARING OFF AND IT BEING UNABLE TO HOLD THE KNIFE / BLADE IN PLACE. THIS HAS EVENTUALLY CAUSED THE PACKAGE OVERCUT. THE PRODUCTION TECHNICIAN HAS REPLACED THE PERFORATION HOLDER AND SCREWS. THE COMPLAINT SAMPLES COULD BE ESCAPEES AS A RESULT OF POOR CONTAINMENT. THE PRIMARY PACKAGING YEARLY PREVENTATIVE MAINTENANCE CHECKLIST HAS BEEN UPDATED TO INCLUDE CHECKING THE CONDITION OF THE PERFORATION KNIFE HOLDER, CHANGING, AND REPLACING IF REQUIRED. A NEW FORM HAS BEEN CREATED TO IMPROVE THE BACKTRACKING PROCESS AND THE REPORTED LOT WAS PRODUCED BEFORE THE NEW FORM HAD BEEN RELEASED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SLIP TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE PACKAGING SEAL WAS NOT TIGHT, AND THE NEEDLE FELL OFF IN THE PACKAGING UNIT, COMPROMISING THE DEVICE'S STERILITY. THIS OCCURRED WITH 12 UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STERILE PACKAGING IN THE BOX CANNOT BE TIGHTLY SEALED, CAUSING THE NEEDLE TO FALL OFF INCIDENT OCCUR : BEFORE USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SLIP TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE PACKAGING SEAL WAS NOT TIGHT, AND THE NEEDLE FELL OFF IN THE PACKAGING UNIT, COMPROMISING THE DEVICE'S STERILITY. THIS OCCURRED WITH 12 UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STERILE PACKAGING IN THE BOX CANNOT BE TIGHTLY SEALED, CAUSING THE NEEDLE TO FALL OFF. INCIDENT OCCUR : BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084209 BD SLIP TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 1231367

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown