BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11168346 · Received January 13, 2021

    Report

    Report Number
    9616657-2021-00004
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 10, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-02-01. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0223175. THE REVIEW DID REVEAL ONE NON-CONFORMANCE DURING THE PRODUCTION PROCESS. THIS NON-CONFORMANCE WAS ASSOCIATED WITH DRY BARRELS. THIS ISSUE WAS RESOLVED AT THE TIME OF OCCURRENCE. TO AID IN THE INVESTIGATION OF THIS INCIDENT, SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH INSPECTION OF THE SAMPLES, THE PLUNGER EXHIBITED DIFFICULT MOVEMENT. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN INTERMITTENT ISSUE DURING PRODUCTION IN WHICH AN INCORRECT DOSE OF SILICON WAS SUPPLIED INTO THE BARREL. DESPITE THE RELATED NON-CONFORMANCE BEING DETECTED AND RESOLVED AT THE TIME OF OCCURRENCE, IT IS POSSIBLE THAT SOME FAULTY PRODUCT WAS PRODUCED PRIOR TO DETECTION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGE THE PLUNGER WAS DIFFICULT TO DEPRESS. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES THAT COULD NOT BE FULLY DEPRESSED AS THE PLUNGER COULD NOT BE ADVANCED FULLY. 1.THE SYRINGES WERE IN A BOX SHIPPED TO US. THE FAULTY SYRINGES WERE NOTED INTERMITTENTLY UNTIL IV TREATMENT ENDED (B)(6) 2020. 2. I HAVE 9 FAULTY SYRINGES; IT IS UNCLEAR HOW MANY MORE OF THE 12 REMAINING UNUSED SYRINGES IN THE BOX ARE DEFECTIVE. 3. NO INJURIES WERE SUSTAINED. 4. I WILL BE ABLE TO RETURN THE FAULTY SYRINGES.

    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 WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGE THE PLUNGER WAS DIFFICULT TO DEPRESS. THIS OCCURRED ON 9 SEPARATE OCCASIONS, HOWEVER, THE PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES THAT COULD NOT BE FULLY DEPRESSED AS THE PLUNGER COULD NOT BE ADVANCED FULLY. THE SYRINGES WERE IN A BOX SHIPPED TO US. THE FAULTY SYRINGES WERE NOTED INTERMITTENTLY UNTIL IV TREATMENT ENDED (B)(6) 2020. I HAVE 9 FAULTY SYRINGES; IT IS UNCLEAR HOW MANY MORE OF THE 12 REMAINING UNUSED SYRINGES IN THE BOX ARE DEFECTIVE. NO INJURIES WERE SUSTAINED. I WILL BE ABLE TO RETURN THE FAULTY SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54961 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 0223175 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1