BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10452161 · Received August 25, 2020

    Report

    Report Number
    9616657-2020-00132
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 24, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Removal / Correction Number
    MDS-20-1971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR WAS PERFORMED. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH AND THERE WAS NO RECORD OF NON-CONFORMANCE ASSOCIATED WITH THIS BATCH. ALTHOUGH SAMPLES WERE NOT AVAILABLE FOR THIS REPORTED INCIDENT, THE DAMAGED PACKAGING IS A KNOWN ISSUE FOR THE REPORTED LOT NUMBER (LOT: 9248167). THE PACKAGE DAMAGE HAS BEEN ISOLATED TO PRODUCT MANUFACTURED ON A SINGLE PACKAGING LINE, WHICH HAS CEASED PRODUCTION SINCE OCTOBER 2019. ALL AFFECTED PRODUCT HAS BEEN PLACED ON HOLD AND A FIELD SAFETY NOTICE, MDS-20-1971, HAS BEEN ISSUED IN RESPONSE TO THIS ISSUE. A CORRECTIVE AND PREVENTIVE ACTION, CAPA#1472544 PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS DEFECT AND IDENTIFY ITS EXACT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED DAMAGED OR OPEN UNIT SEALS/PACKAGES WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN PACKAGING, THE LOT NUMBER IS ON THE "RECALL-LIST" THAT HAS BEEN SEND OUT TO ALL THE CUSTOMER 1TH OF JULY.

    Additional Manufacturer Narrative · 1

    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% EXPERIENCED DAMAGED OR OPEN UNIT SEALS/PACKAGES WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN PACKAGING, THE LOT NUMBER IS ON THE "RECALL-LIST" THAT HAS BEEN SEND OUT TO ALL THE CUSTOMER 1TH OF JULY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916661 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 9248167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other