BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 11237099 · Received January 27, 2021

    Report

    Report Number
    2243072-2021-00169
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE BRAND NAME: SYRINGE 5ML LL TIP BULK CONVENIENCE PAK D4: CATALOG # 309703 D4: UDI # (B)(6) G.5. PMA / 510(K)#: K110771 THE FOLLOWING ARE POTENTIAL LOT NUMBERS: D4: MEDICAL DEVICE LOT #: 9280144 D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4: DEVICE MANUFACTURE DATE: UNKNOWN D4: MEDICAL DEVICE LOT #: 9246097 D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4: DEVICE MANUFACTURE DATE: UNKNOWN H6: INVESTIGATION SUMMARY A REVIEW OF THE PRODUCTION HISTORY RECORDS WAS PERFORMED FOR THE PROVIDED POTENTIAL LOT NUMBERS, 9280144 AND 9246097 AND ALL APPLICABLE SUB-ASSEMBLY LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES OR QUALITY NOTIFICATIONS DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL IN-PROCESS INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. AFTER PACKAGING, THE CONVENIENCE TRAY PRODUCT IS SENT FOR COBALT RADIATION STERILIZATION. THIS STERILIZATION PROCESS WAS ALSO REVIEWED AND IT WAS DETERMINED THAT THE STERILIZATION DOSE FOR THE RELATED LOT NUMBERS WAS WITHIN THE TARGET RANGE; THEREFORE, NO ISSUES WITH STERILIZATION COULD BE IDENTIFIED. ALTHOUGH SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, THE SAMPLES WERE RECEIVED OUTSIDE OF THE ORIGINAL PACKAGING AND THEREFORE, WERE NO LONGER STERILE. DUE TO THE LACK OF STERILITY, ADDITIONAL TESTING FOR THE ALLEGED CONTAMINATION WAS NOT POSSIBLE. ONCE THE PRODUCT PACKAGING IS OPEN OR TAMPERED WITH, WE WOULD BE UNABLE TO CONFIRM IF ANY CONTAMINATION WAS RELATED TO THE BD MANUFACTURING PROCESS. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD SYRINGE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN; BATCH NO.: UNKNOWN. IT WAS REPORTED THAT A SYRINGE WAS DEEMED QUESTIONABLE UPON INSPECTION. IT WAS CLARIFIED THAT THERE IS GROWTH WITHIN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: TWO POTENTIAL LOT #S WERE PROVIDED AS 9280144 AND 9246097. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD SYRINGE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: UNKNOWN BATCH NO.: UNKNOWN IT WAS REPORTED THAT A SYRINGE WAS DEEMED QUESTIONABLE UPON INSPECTION. IT WAS CLARIFIED THAT THERE IS GROWTH WITHIN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134105 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1