BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN.

    MDR report key: 14196932 · Received April 25, 2022

    Report

    Report Number
    1213809-2022-00236
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096252
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 EVALUTION?: YES, D9: RETURNED TO MANUFACTURER ON: 09-MAY-2022 H6: INVESTIGATION SUMMARY SIXTY-EIGHT PACKAGED 1ML SYRINGES (P/N 309625) WITH NEEDLE FROM BATCH 9151836 SAMPLES WERE RECEIVED. EACH SAMPLE WAS TESTED FOR SHIELD REMOVAL FORCES. TWENTY-THREE SAMPLES WERE FOUND TO HAVE SHIELD REMOVAL FORCES BEYOND THE MAXIMUM SPECIFICATION. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE TIGHT SHIELD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 9151836 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN., THAT NEEDLE HUB COMES OFF WITH SHIELD REMOVAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT WHEN HE TRIES TO REMOVE THE SHIELD THE NEEDLE HUB COMES OFF WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN., THAT NEEDLE HUB COMES OFF WITH SHIELD REMOVAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT WHEN HE TRIES TO REMOVE THE SHIELD THE NEEDLE HUB COMES OFF WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196291 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 3/8 IN. PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309625 9151836 30382903096252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown