BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 6849997 · Received September 7, 2017

    Report

    Report Number
    9616657-2017-00007
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 14, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE REPORTED BATCH NUMBERS 6336735, 7023864, AND 7059938. SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO EVIDENCE OF LEAKAGE OR DAMAGE WAS OBSERVED ON THE RETURNED SAMPLES. INVESTIGATION CONCLUSION: LOT: 6336735 - SAMPLES WERE RECEIVED. THE RETURNED SAMPLES DID NOT EXHIBIT ANY EVIDENCE OF LEAKAGE. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH; THERE WERE NO NON-CONFORMANCES WHICH COULD POTENTIALLY RELATE TO THIS DEFECT. THE COMPLAINT IS UNCONFIRMED. THE PRODUCT WAS WITHIN SPECIFICATIONS. THE DHR AND QN'S WERE REVIEWED FOR THIS LOT OF POSIFLUSH AND THERE WERE NO DEFECTS RECORDED WHICH COULD CONTRIBUTE TO THE FAILURE MODE RECORDED IN THIS COMPLAINTS. LOT: 7023864 - SAMPLE RECEIVED FOR INVESTIGATION. THE RETURNED SAMPLES DID NOT EXHIBIT ANY EVIDENCE OF LEAKAGE. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH; THERE WERE NO NON-CONFORMANCES WHICH COULD POTENTIALLY RELATE TO THIS DEFECT. THE COMPLAINT IS UNCONFIRMED. THERE WERE NO REPORTS OF DAMAGED OR LEAKING SYRINGES DURING THE MANUFACTURE OF THIS BATCH. THE PRODUCT WAS WITHIN SPECIFICATIONS. THE DHR AND QN'S WERE REVIEWED FOR THIS LOT OF POSIFLUSH AND THERE WERE NO DEFECTS RECORDED WHICH COULD CONTRIBUTE TO THE FAILURE MODE RECORDED IN THE COMPLAINT. LOT: 7059938 - SAMPLE RECEIVED FOR INVESTIGATION. THE RETURNED SAMPLES DID NOT EXHIBIT ANY EVIDENCE OF LEAKAGE. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH; THERE WERE NO NON-CONFORMANCES WHICH COULD POTENTIALLY RELATE TO THIS DEFECT. THE COMPLAINT IS UNCONFIRMED. THERE WERE NO REPORTS OF DAMAGED OR LEAKING SYRINGES DURING THE MANUFACTURE OF THIS BATCH. THE PRODUCT WAS WITHIN SPECIFICATIONS. THE DHR AND QN'S WERE REVIEWED FOR THIS LOT OF POSIFLUSH AND THERE WERE NO DEFECTS RECORDED WHICH COULD CONTRIBUTE TO THE FAILURE MODE RECORDED IN THE COMPLAINT. ROOT CAUSE DESCRIPTION: PRODUCT IS WITHIN SPECIFICATIONS. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THREE POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6336735, MEDICAL DEVICE EXPIRATION DATE: 11/30/2019, DEVICE MANUFACTURE DATE: 12/01/2016. MEDICAL DEVICE LOT #: 7023864, MEDICAL DEVICE EXPIRATION DATE: 12/31/2019, DEVICE MANUFACTURE DATE: 01/23/2017. MEDICAL DEVICE LOT #: 7059938, MEDICAL DEVICE EXPIRATION DATE: 01/31/2020, DEVICE MANUFACTURE DATE: 02/28/2017. 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 SALINE LEAKED THROUGH THE BOTTOM OF A BD POSIFLUSH¿ XS 10 ML PRE-FILLED FLUSH SYRINGE NACL 0.9% DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629612 BD POSIFLUSH¿ XS 10ML PRE-FILLED FLUSH SYRINGE NACL 0.9% PREFILLED SALINE FLUSH SYRINGE NGT BECTON, DICKINSON AND CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other