BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 9385451 · Received November 27, 2019

    Report

    Report Number
    9616657-2019-00375
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 13, 2019
    Report Date
    January 20, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION: DEVICE RETURNED WITH SPOTS ON PACKAGING THE DHR WERE REVIEWED FOR THIS BATCH AND THERE WAS NO RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THIS COMPLAINT WAS CREATED DURING THE STEAM STERILIZATION PROCESS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% THERE WERE ISSUES WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE HEREBY INFORM YOU THAT FOLLOWING IN-PROCESS CHECKS WE HAVE FOUND THE FOLLOWING ISSUES REGARDING THE FOLLOWING DELIVERIES OF COD. 306572 [REF. DRM: CODE BD SALINE XS]: LOT 9142652 - PCS PRE-CUT (34), PCS SPOTS ON PACKAGING (122), PCS SPOTS ON SYRINGE (12), PCS MISSING (2). LOT 9182101 - PCS PRE-CUT (16), PCS SPOTS ON PACKAGING (40), PCS CORPUSCLES WELDING (12). LOT 9199773 - PC PRE-CUT (10), PCS SPOTS ON PACKAGING (104), PZ. CORPUSCLES WELDING (7). LOT 9178438 - PC PRE-CUT (9), PCS SPOTS ON PACKAGING (18), PCS CORPUSCLES WELD (19), PCS STAINS ON SYRINGE (2), PCS MISSING (10). LOT 9213635 - PC PRE-CUT (30), PCS STAINS ON PACKAGING (34), PCS STAINS ON SYRINGE (1)

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9142652. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-22. MEDICAL DEVICE LOT #: 9182101. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-07-01. MEDICAL DEVICE LOT #: 9199773. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-07-18. MEDICAL DEVICE LOT #: 9178438 . MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-06-27. MEDICAL DEVICE LOT #: 9213635. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-08-01. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% THERE WERE ISSUES WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE HEREBY INFORM YOU THAT FOLLOWING IN-PROCESS CHECKS WE HAVE FOUND THE FOLLOWING ISSUES REGARDING THE FOLLOWING DELIVERIES OF COD. 306572: LOT 9142652 - PCS PRE-CUT (34), PCS SPOTS ON PACKAGING (122), PCS SPOTS ON SYRINGE (12), PCS MISSING (2). LOT 9182101 - PCS PRE-CUT (16), PCS SPOTS ON PACKAGING (40), PCS CORPUSCLES WELDING (12). LOT 9199773 - PC PRE-CUT (10), PCS SPOTS ON PACKAGING (104), PZ. CORPUSCLES WELDING (7). LOT 9178438 - PC PRE-CUT (9), PCS SPOTS ON PACKAGING (18), PCS CORPUSCLES WELD (19), PCS STAINS ON SYRINGE (2), PCS MISSING (10). LOT 9213635 - PC PRE-CUT (30), PCS STAINS ON PACKAGING (34), PCS STAINS ON SYRINGE (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182337 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other