BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 20874851 · Received December 8, 2024

    Report

    Report Number
    9616657-2024-00035
    Event Type
    Malfunction
    Date Received
    December 8, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBERS 4050231, 4137938, 4067519, 4082028, AND 4043303. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS FOR LOT NUMBERS 4050231, 4137938, 4082028, AND 4043303 THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. THE REVIEW DID IDENTIFY A POSSIBLE NON-CONFORMANCE DURING THE PRODUCTION PROCESS FOR LOT NUMBER 4067519 THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. THE NON-CONFORMANCE WAS RELATED TO PACKAGE PERFORATION. FOR LOT NUMBER 4067519, IT IS PROBABLE THAT THE REPORTED INCIDENT RESULTED FROM THE CROSS-CUT BLADE ON THE MULTIVAC MACHINERY. THESE BLADES WERE REPLACED AT THE TIME OF THE DETECTED NON-CONFORMANCE; HOWEVER, THE ISSUE MAY HAVE BEEN INTERMITTENT PRIOR TO THE POINT OF DISCOVERY, RESULTING IN SOME DEFECTIVE PRODUCT GETTING RELEASED. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED; HOWEVER, THE PICTURE SAMPLE DID NOT SHOW THE REPORTED DEFECT. A SIGNIFICANT AMOUNT OF IN PROCESS TESTING IS PERFORMED DURING THE MANUFACTURE OF EACH POSIFLUSH LOT PRODUCED. THE BLISTER PACK MACHINE OPERATOR CHECKS TWENTY (20) UNITS PER HOUR AND THE SECONDARY PACKING OPERATOR CHECKS A FURTHER THIRTY (30) UNITS PER HOUR. IN ADDITION, FINAL INSPECTION IS PERFORMED ON THIRTY (30) UNITS PER PALLET BY QUALITY CONTROL INSPECTORS. THERE WERE NO REPORTS OF POOR PERFORATIONS DURING ANY OF THESE INSPECTIONS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT THIS DEFECT MAY BE CAUSED BY THE INCORRECT METHOD OF SEPARATION. IT IS RECOMMENDED THAT BLISTERS ARE SEPARATED ON A HORIZONTAL PLANE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D. ADDITIONAL BATCH NUMBERS REPORTED WITH THIS ISSUE BY THIS CUSTOMER FOR MATERIAL #306572: 4050231 MFG 2024-02-19 EXP 2027-01-31. 4137938 MFG 2024-05-16 EXP 2027-04-30. 4067519 MFG 2024-03-07 EXP 2027-02-28. 4082028 MFG 2024-03-22 EXP 2027-02-28. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH-XS/SF POUCH PERFORATION PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DEFECTIVE STERILE PACKAGING/PERFORATION. POOR PERFORATION; THEREFORE, THE STERILE PACKAGING IS DAMAGED WHEN IT IS TORN OFF. WHEN DID THE INCIDENT OCCUR? BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468371 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4043303 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown