BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10537660 · Received September 15, 2020

    Report

    Report Number
    9616657-2020-00149
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: 9/16/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0167451 AND 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, PACKAGE DAMAGE WAS OBSERVED. THIS ISSUE HAS BEEN INVESTIGATED WITH ENGINEERING LEADERSHIP; HOWEVER, AT THIS POINT A SINGLE CAUSE HAS NOT BEEN DETERMINED. A CORRECTIVE AND PREVENTIVE ACTION PLAN, CAPA#1833142, HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ITS RECURRENCE. THE CURRENT FOCUS OF THE INVESTIGATION IS ON THE HANDLING AND PACKAGING PROCESS OF THE BLISTER PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PACKAGING WAS "BENT INTO A BANANA SHAPE", WHICH PIERCED THROUGH THE TOP WEB SEAL DUE TO THE TENSION OF THE DAMAGE. THIS WAS FOUND WITH 5 UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS JUST DISCUSSED ON THE PHONE, YOUR PRODUCT POSIFLUSH (REF 306572 WITH BATCH/LOT 0167451) HAS A SERIOUS STERILITY PROBLEM. THE PRODUCT SEEMS TO HAVE BEEN SUBJECTED TO A CONSIDERABLE VACUUM DURING STERILIZATION. ALL PACKAGING HAS CONTRACTED AND IS BENT INTO A BANANA SHAPE. DUE TO THE RESULTING TENSION, THE PACKAGING ON THE PAPER TOP WEB IS ALWAYS PIERCED IN THE AREA OF THE RETAINING PLATE. AFTER 100% VISUAL INSPECTION, UP TO 5 PRODUCTS ARE NON-STERILE IN A 30-PACKAGING UNIT. THIS CORRESPONDS TO A DRAMATIC REJECT RATE OF 16.67%."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. HA 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 THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PACKAGING WAS "BENT INTO A BANANA SHAPE", WHICH PIERCED THROUGH THE TOP WEB SEAL DUE TO THE TENSION OF THE DAMAGE. THIS WAS FOUND WITH 5 UNITS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS JUST DISCUSSED ON THE PHONE, YOUR PRODUCT POSIFLUSH (REF 306572 WITH BATCH/LOT 0167451) HAS A SERIOUS STERILITY PROBLEM. THE PRODUCT SEEMS TO HAVE BEEN SUBJECTED TO A CONSIDERABLE VACUUM DURING STERILIZATION. ALL PACKAGING HAS CONTRACTED AND IS BENT INTO A BANANA SHAPE. DUE TO THE RESULTING TENSION, THE PACKAGING ON THE PAPER TOP WEB IS ALWAYS PIERCED IN THE AREA OF THE RETAINING PLATE. AFTER 100% VISUAL INSPECTION, UP TO 5 PRODUCTS ARE NON-STERILE IN A 30-PACKAGING UNIT. THIS CORRESPONDS TO A DRAMATIC REJECT RATE OF 16.67%."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002046 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 0167451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other