BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ SF SALINE SYRINGE

    MDR report key: 9844761 · Received March 17, 2020

    Report

    Report Number
    9616657-2020-00047
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 3, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Removal / Correction Number
    MDS-20-1971-FA
    Adverse Event
    Yes
    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 HAVE BEEN UPDATED WITH CORRECTIONS: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL (MDS-20-1971-FA) FOR MULTIPLE LOTS OF THE BD POSIFLUSH¿ SF (STERILE FIELD) SALINE FLUSH SYRINGE 10ML AND THE BD POSIFLUSH¿ XS (EXTERNALLY STERILE) 10 ML SYRINGE. THIS PRODUCT HAS BEEN CONFIRMED TO EXHIBIT HOLES IN THE PACKAGING, WHICH IMPACTS PACKAGE INTEGRITY AND POTENTIALLY COMPROMISES A STERILE FIELD. WHILE THE STERILITY OF THE OUTER SURFACE OF THE SYRINGE MAY BE COMPROMISED, THE SALINE SOLUTION AND THE STERILE PATH OF THE SYRINGE ARE NOT IMPACTED. THE ROOT CAUSE INVESTIGATION IS ONGOING AND WILL BE DOCUMENTED IN CAPA # 1472554; HOWEVER, THE ISSUE HAS BEEN ISOLATED TO PRODUCT MANUFACTURED USING ONE SINGLE PACKAGING LINE. D.10. DEVICE AVAILABLE FOR EVAL? NO. H.7. REMEDIAL ACTION REQUIRED: RECALL. H.9. REMEDIAL ACTION #: MDS-20-1971-FA.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9011582 AND 9045702. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS OF EITHER LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS ISSUE, PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE FLANGE COMPONENT WAS OBSERVED THROUGH THE PRODUCT PACKAGING. IT HAS BEEN DETERMINED THAT THIS INCIDENT MAY HAVE RESULTED FROM A MISALIGNMENT OF THE SYRINGE FLANGE COMPONENT WITHIN THE BLISTER PACKAGES FOLLOWING THE ROBOT TRANSFER FROM THE SYRINGE LOADER TO THE STERILISER TRAYS PRIOR TO STERILISATION. ADDITIONAL ROOT CAUSES ARE BEING EXPLORED, INCLUDING POST STERILISATION HANDLING CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE HAD A DAMAGED PACKAGE. THIS OCCURRED ON 981 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306553 BATCH NO.: 9011582, 9045702. IT WAS REPORTED SLITS IN THE POUCHES. PER EMAIL: WE HAVE SOME ADDITIONAL SYRINGES THAT HAVE BEEN SORTED AND FOUND TO BE DISCREPANT (SLITS IN THE POUCHES). TOTAL QUANTITY IS 981 PIECES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE HAD A DAMAGED PACKAGE. THIS OCCURRED ON 981 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306553 BATCH NO.: 9011582, 9045702. IT WAS REPORTED SLITS IN THE POUCHES. PER EMAIL: WE HAVE SOME ADDITIONAL SYRINGES THAT HAVE BEEN SORTED AND FOUND TO BE DISCREPANT (SLITS IN THE POUCHES). TOTAL QUANTITY IS (B)(4) PIECES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9045702, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2019-02-14, MEDICAL DEVICE LOT #: 9011582, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-01-11. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE HAD A DAMAGED PACKAGE. THIS OCCURRED ON 981 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306553, BATCH NO.: 9011582, 9045702. IT WAS REPORTED SLITS IN THE POUCHES. PER EMAIL: WE HAVE SOME ADDITIONAL SYRINGES THAT HAVE BEEN SORTED AND FOUND TO BE DISCREPANT (SLITS IN THE POUCHES). TOTAL QUANTITY IS 981 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309240 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 306553 SEE H.10 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other