BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 9355464 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00616
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 301948 LOT 1811364 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE RETURNED SAMPLE UNDER A MICROSCOPE PRESENTED A RUBBER PARTICLE INSIDE THE CANNULA WHICH PRODUCED THE CLOGGED NEEDLE ISSUE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE AND THE DEVICE HISTORY REVIEW, THE CORING EFFECT IS UNLIKELY TO BE CAUSED BY POOR OR AN INSUFFICIENT DE-BURRING PROCESS OF THE CANNULA. AS PART OF THE BD FRAGA CANNULA INCOMING INSPECTION, VISUAL EXAMINATION, MEASUREMENTS AND PENETRATION TEST ARE PERFORMED. IN ADDITION, THE STOPPER AND THE TECHNIQUE USED TO PENETRATE THE VIAL CANNOT BE EXCLUDED TO PLAY A ROLE AND HAVE SOME POTENTIAL IMPLICATION IN THE CORING EFFECT ISSUES. SINCE MOST OF THE NEEDLES HAVE A SHORT BEVEL LIKE THE REPORTED ONE, THE NEEDLE SHOULD PENETRATE THE STOPPER AT 90º TO AVOID HAVING CORING EFFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. CONCLUSION: NOT POSSIBLE TO DETERMINE. POSSIBLE INCORRECT HANDLING OF THE PRODUCT DURING USE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE WITH NEEDLE HAS BEEN FOUND CLOGGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON AUGUST 16, 2019, REP. RECEIVED A COMPLAINT FROM. THE SYRINGE HAD NO ABNORMALITY WHEN THE PACKAGE WAS OPENED FOR THE FIRST TIME, BUT FOUND THE NEEDLE CLOGGED WHEN THE DRUG WAS PUMPED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE WITH NEEDLE HAS BEEN FOUND CLOGGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, REP. RECEIVED A COMPLAINT FROM. THE SYRINGE HAD NO ABNORMALITY WHEN THE PACKAGE WAS OPENED FOR THE FIRST TIME, BUT FOUND THE NEEDLE CLOGGED WHEN THE DRUG WAS PUMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154021 BD SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1811364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other