BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10248324 · Received July 8, 2020

    Report

    Report Number
    9616657-2020-00102
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/29/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0111366, 9255893, AND 0105650. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE PRODUCT PACKAGING WAS OBSERVED TORN. ALL OF THE SAMPLES RETURNED WERE FOUND TO HAVE PROPER PERFORATION, THEREFORE, A CAUSE FOR THE TORN PACKAGES COULD NOT BE ASSIGNED. PREVIOUS INVESTIGATIONS FOR THIS TYPE OF ISSUE HAVE IDENTIFIED THAT THIS MAY RESULT FROM AN INCORRECT METHOD OF SEPARATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% FROM LOTS 9255893, 0105650, AND 0111366 HAD POOR PERFORATION ON THEIR PACKAGING UNITS BEFORE USE. THIS MADE THEM DIFFICULT TO TEAR APART, RESULTING IN PAPER PACKAGING SHARDS ENTERING A STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WE THINK THAT THE PRE-CUTTING IS NOT MARKED ENOUGH, CONSEQUENTLY THIS DEFECT CAUSES A LOSS OF TIME IN PRODUCTION AND THE TEARING OF THE INDIVIDUAL BAG MAKES THE SYRINGES UNUSABLE (THEY ARE USED IN OUR CONDITIONED PRODUCTION THEREFORE STERILE). DESCRIPTION : DIFFICULTY IN REMOVING THE INDIVIDUAL BAG OF SYRINGES. 135 BLOCKED QUANTITIES BATCH/ LOT: 9255893/0105650/0111366. FOR YOUR NOTICE, IN 2019, SIMILAR DEFECT BUT FOR A DIFFERENT LOT".

    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 #: 9255893, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-09-12, MEDICAL DEVICE LOT #: 0105650, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-04-14, MEDICAL DEVICE LOT #: 0111366, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-04-20. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% FROM LOTS 9255893, 0105650, AND 0111366 HAD POOR PERFORATION ON THEIR PACKAGING UNITS BEFORE USE. THIS MADE THEM DIFFICULT TO TEAR APART, RESULTING IN PAPER PACKAGING SHARDS ENTERING A STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WE THINK THAT THE PRE-CUTTING IS NOT MARKED ENOUGH, CONSEQUENTLY THIS DEFECT CAUSES A LOSS OF TIME IN PRODUCTION AND THE TEARING OF THE INDIVIDUAL BAG MAKES THE SYRINGES UNUSABLE (THEY ARE USED IN OUR CONDITIONED PRODUCTION THEREFORE STERILE). DESCRIPTION: DIFFICULTY IN REMOVING THE INDIVIDUAL BAG OF SYRINGES. 135 BLOCKED QUANTITIES, BATCH/ LOT: 9255893/0105650/0111366. FOR YOUR NOTICE, IN 2019, SIMILAR DEFECT BUT FOR A DIFFERENT LOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712578 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other