BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SF SALINE SYRINGE

    MDR report key: 11181420 · Received January 15, 2021

    Report

    Report Number
    9616657-2021-00005
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 15, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0174571 AND 0251351. 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, TEARS AND HOLES WERE OBSERVED WITHIN THE PRODUCT PACKAGING TOP WEB. A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA) 1833142 WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE WITH PLANT ENGINEERING LEADERSHIP AND TO TRACK THE SUBSEQUENT CORRECTIVE ACTIONS. THROUGH THE PLAN, VARIOUS POTENTIAL ROOT CAUSES HAVE BEEN IDENTIFIED AND ARE CONTINUING TO BE ANALYZED BY OUR QUALITY TEAM. ONCE THE ROOT CAUSE IS DETERMINED AND CORRECTIVE ACTIONS ARE IMPLEMENTED, VERIFICATION AND EFFECTIVENESS TESTING SHALL BE PERFORMED TO ENSURE THE ISSUE HAS BEEN HANDLED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD POSIFLUSH¿ SF SALINE SYRINGES HAD DAMAGED PACKAGING UNITS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ASSEMBLY, TEARS/HOLES WERE OBSERVED IN THE PACKAGING OF THIRTEEN (13) OF THE SYRINGES. THE TEARS WERE CAUSING A BREACH IN THE STERILE BARRIER. THE SYRINGES WITH THE OBSERVED DAMAGE CAME FROM LOTS 0174571 AND 0251351. FOUR OF THE SYRINGES WITH DAMAGE WERE INADVERTENTLY DISCARDED. HOWEVER, NINE (9) ARE AVAILABLE FOR RETURN. OF THE NINE (9) NONCONFORMING SYRINGES, THE TEAR IS LOCATED IN THE SAME LOCATION FOR EIGHT (8) OF THE UNITS- IN THE TYVEK DIRECTLY ABOVE THE BARREL FLANGE. THE LOCATION OF THE OTHER (1) HOLE IS LOCATED ON THE POLY SIDE OF THE PACKAGING BUT ALSO IN DIRECT ALIGNMENT WITH THE BARREL FLANGE. DUE TO THE ISSUE DESCRIBED ABOVE, 100% INSPECTION WAS PERFORMED ON 800 OF THE SYRINGES IN INVENTORY (LOT 0251351). THE SYRINGES WERE OPENED FROM THEIR ORIGINAL PACKAGING AND VISUALLY INSPECTED FOR DAMAGE (HOLES, TEARS, OR ANY BREACHES TO THE STERILE BARRIER). FOUR (4) SYRINGES WERE FOUND TO BE NONCONFORMING. ONE (1) OF THE SYRINGES HAD A TEAR IN THE TYVEK IN THE SAME LOCATION DESCRIBED ABOVE (ALIGNED WITH BARREL FLANGE) AND THREE (3) UNITS HAD "WEARING" IN THIS LOCATION.

    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 9 BD POSIFLUSH¿ SF SALINE SYRINGES HAD DAMAGED PACKAGING UNITS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ASSEMBLY, TEARS/HOLES WERE OBSERVED IN THE PACKAGING OF THIRTEEN (13) OF THE SYRINGES. THE TEARS WERE CAUSING A BREACH IN THE STERILE BARRIER. THE SYRINGES WITH THE OBSERVED DAMAGE CAME FROM LOTS 0174571 AND 0251351. FOUR OF THE SYRINGES WITH DAMAGE WERE INADVERTENTLY DISCARDED. HOWEVER, NINE (9) ARE AVAILABLE FOR RETURN. OF THE NINE (9) NONCONFORMING SYRINGES, THE TEAR IS LOCATED IN THE SAME LOCATION FOR EIGHT (8) OF THE UNITS- IN THE TYVEK DIRECTLY ABOVE THE BARREL FLANGE. THE LOCATION OF THE OTHER (1) HOLE IS LOCATED ON THE POLY SIDE OF THE PACKAGING BUT ALSO IN DIRECT ALIGNMENT WITH THE BARREL FLANGE. DUE TO THE ISSUE DESCRIBED ABOVE, 100% INSPECTION WAS PERFORMED ON 800 OF THE SYRINGES IN INVENTORY (LOT 0251351). THE SYRINGES WERE OPENED FROM THEIR ORIGINAL PACKAGING AND VISUALLY INSPECTED FOR DAMAGE (HOLES, TEARS, OR ANY BREACHES TO THE STERILE BARRIER). FOUR (4) SYRINGES WERE FOUND TO BE NONCONFORMING. ONE (1) OF THE SYRINGES HAD A TEAR IN THE TYVEK IN THE SAME LOCATION DESCRIBED ABOVE (ALIGNED WITH BARREL FLANGE) AND THREE (3) UNITS HAD "WEARING" IN THIS LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76097 BD POSIFLUSH SF SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 306553 0174571 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1