BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32X4 ITALY VIG

    MDR report key: 12055418 · Received June 23, 2021

    Report

    Report Number
    9616656-2021-00726
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 9, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-10-04 H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 0309952, CAT. NO. 320140. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. A FUNCTIONALITY TEST WAS ALSO CARRIED OUT AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PN 32X4 ITALY VIG NEEDLE WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT DURING THE INJECTION THE PISTON DID NOT MOVE AS USUAL AND THAT THE INNER PART OF THE NEEDLE WAS DEVOID OF THE PART THAT NORMALLY GOES INTO THE RUBBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PN 32X4 ITALY VIG NEEDLE WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT DURING THE INJECTION THE PISTON DID NOT MOVE AS USUAL AND THAT THE INNER PART OF THE NEEDLE WAS DEVOID OF THE PART THAT NORMALLY GOES INTO THE RUBBER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. INITIAL REPORTER PHONE# : (B)(6). A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE : UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 PN 32X4 ITALY VIG NEEDLE WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT DURING THE INJECTION THE PISTON DID NOT MOVE AS USUAL AND THAT THE INNER PART OF THE NEEDLE WAS DEVOID OF THE PART THAT NORMALLY GOES INTO THE RUBBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944210 PN 32X4 ITALY VIG HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown