BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12802533 · Received November 12, 2021

    Report

    Report Number
    9616657-2021-00092
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 10, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6) 2021. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1160335. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE SYRINGE SAMPLE WITH OPEN PACKAGING WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, A SMALL AIR BUBBLE COULD BE OBSERVED. HOWEVER, THE AIR BUBBLE APPEARED TO RECEDE BY SLIGHTLY TURNING AND GENTLY PRODDING THE SYRINGE. THIS IS THE FIRST REPORT RECEIVED FOR AIR BUBBLES ON MATERIAL 306572 & LOT NUMBER 1160335. A THIRD-PARTY CATHETER ACCESSORY WAS ATTACHED TO THE SYRINGE UPON RECEIPT. THE SYRINGE¿S LUER COMPONENT WAS TESTED AND INSPECTED FOR SIGNS OF DAMAGE, SINK MARKS, LUER ANGLE, OR ANY OTHER POTENTIAL DEFECT. NONE OF THE INSPECTIONS PERFORMED WERE ABLE TO CONFIRM THE REPORTED INCIDENT IN RELATION TO THE BD POSIFLUSH SYRINGE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% EXPERIENCED A CASE OF LEAKAGE, A CASE OF AIR IN SYRINGE, AND A CASE OF A DAMAGED SYRINGE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION LEAKS ON KTC. AIR IN THE TUBING. SCREW THREAD BI-DIRECTIONAL VALVE "AUTO-FLUSH" (IN CENTRAL KT KIT) BROKEN. THERE WAS NO CONSEQUENCE FOR THE PATIENT BUT THERE COULD HAVE BEEN SOME SINCE AIR WAS FOUND IN THE TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% EXPERIENCED A CASE OF LEAKAGE, A CASE OF AIR IN SYRINGE, AND A CASE OF A DAMAGED SYRINGE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION LEAKS ON KTC. AIR IN THE TUBING. SCREW THREAD BI-DIRECTIONAL VALVE "AUTO-FLUSH" (IN CENTRAL KT KIT) BROKEN. THERE WAS NO CONSEQUENCE FOR THE PATIENT BUT THERE COULD HAVE BEEN SOME SINCE AIR WAS FOUND IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702930 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PREFILLED SALINE SYRINGE NGT BECTON, DICKINSON AND CO. 1160335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown