BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE CLIPPER SAFE-CLIP EUROPE

    MDR report key: 13862263 · Received March 23, 2022

    Report

    Report Number
    2243072-2022-00376
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 5, 2022
    Report Date
    April 21, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE LOT #: 8250018 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT #: 8250018 . D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 07-SEP-2018. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 29-MAR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED A SAFECLIP FROM LOT 8250018. VISUAL INSPECTION FOUND LIMITED AMOUNTS OF OBSERVABLE WEAR TO THE SAFECLIP. AN ATTEMPT WAS MADE TO INSERT A SPARE PEN NEEDLE INTO THE MOUTH OF THE SAFECLIP. DESPITE THE CANNULA LINING UP PROPERLY WITH THE MOUTH OF THE SAFECLIP, THIS PROCESS WAS DIFFICULT AND TOOK SIGNIFICANT FINESSE TO ACCOMPLISH. UNDER OPTIMAL CIRCUMSTANCES, THIS ACTION WOULD NOT REQUIRE THIS DEGREE OF EFFORT. WEAR OR MATERIAL BUILD UP AT THE MOUTH OF THE TRIMMER ON THE TRIMMING COMPONENTS MAY HAVE RESULTED IN THE INCREASED DIFFICULT IN INSERTING A CANNULA. 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. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DIFFICULTY USING THE SAFECLIP AS INTENDED. THE ROOT CAUSE OF SAFECLIP BEING DIFFICULT TO OPERATE MAY BE WEAR AND MATERIAL BUILD-UP OVER TIME AS THE RESULT OF USE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEEDLE CLIPPER SAFE-CLIP (B)(4) THE DEVICE WOULDN'T CLIP THE NEEDLES PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT USES A BD SAFE CLIP TO CUT OFF HER NEEDLES. NOW THE DEVICE IS STUCK EVEN THOUGH IT HASN'T BEEN USED MUCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEEDLE CLIPPER SAFE-CLIP EUROPE THE DEVICE WOULDN'T CLIP THE NEEDLES PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT USES A BD SAFE CLIP TO CUT OFF HER NEEDLES. NOW THE DEVICE IS STUCK EVEN THOUGH IT HASN'T BEEN USED MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728696 BD NEEDLE CLIPPER SAFE-CLIP EUROPE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8250018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown