BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 11777657 · Received May 5, 2021

    Report

    Report Number
    2243072-2021-01345
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 5202370. D4: MEDICAL DEVICE LOT #: 9017003. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-25. H4: DEVICE MANUFACTURE DATE:2015-08-20. H4: DEVICE MANUFACTURE DATE:2019-02-20. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) USED BD SAFECLIP DEVICES (1 FROM LOT# 5202370 AND 1 FROM LOT# 9017003). THE CUSTOMER REPORTED THAT THE LATEST [NEEDLE CLIPPERS] I HAVE HAD I HAVE NOT BEEN ABLE TO GET THE CANNULA INTO THE HOLE SO IT CAN BE CUT OFF. BOTH RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT THE CUTTER HOLE FOR BOTH SAFECLIPS WAS BLOCKED WITH CUT CANNULA. DUE TO THE CONDITION OF THE RETURNED SAFECLIP DEVICES NEITHER SAMPLE COULD BE TESTED FOR FUNCTIONALITY. THE LIKELY SCENARIO IS THAT THE SAFE CLIP IS FULL, HAS BEEN USED OVER TIME, AND THERE IS NO ROOM TO STORE ADDITIONAL CANNULA. THIS USUALLY RESULTS AFTER NORMAL USE OF THE PRODUCT AND IS THEREFORE NOT CONFIRMED AS A DEFECT. AT THIS POINT THE USER SHOULD DISPOSE THE SAFE CLIP CORRECTLY AS HE OR SHE WOULD FOR ANY FULL SHARPS COLLECTOR/CONTAINER. ACCORDING WITH THE DHR REVIEW INFORMATION THE PROBLEM ¿DIFFICULT/UNABLE TO OPERATE¿ HAS NO JHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (EURO) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0 AND AQL=0.65). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS THE DEVICE PERFORMED AS INTENDED AND IS NOW LIKELY FULL. THE CAUSE FOR THIS ISSUE IS USER RELATED. THE SAFECLIP PERFORMED AS INTENDED, AND IS NOW LIKELY FULL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE WOULD NOT FIT INTO THE BD SAFE-CLIP¿ HOLE SO IT COULD BE CUT. THIS OCCURRED 10 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: "I HAVE USED YOUR NEEDLE CLIPPER FOR SEVERAL YEARS AND FOUND IT TO BE VERY COMFORTABLE TO BRING IN A POCKET OR A BAG. THE LATEST ONES I HAVE HAD I HAVE NOT BEEN ABLE TO GET THE CANNULA INTO THE HOLE SO IT CAN BE CUT OFF!". "I USE MB 4 AND IT HAS BEEN GOOD UNTIL A COUPLE OF MONTHS BACK. I HAVE TRIED SEVERAL NEEDLE CLIPPERS WITH POOR RESULT.".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: 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 EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, 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 NEEDLE WOULD NOT FIT INTO THE BD SAFE-CLIP¿ HOLE SO IT COULD BE CUT. THIS OCCURRED 10 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: "I HAVE USED YOUR NEEDLE CLIPPER FOR SEVERAL YEARS AND FOUND IT TO BE VERY COMFORTABLE TO BRING IN A POCKET OR A BAG. THE LATEST ONES I HAVE HAD I HAVE NOT BEEN ABLE TO GET THE CANNULA INTO THE HOLE SO IT CAN BE CUT OFF!" "I USE MB 4 AND IT HAS BEEN GOOD UNTIL A COUPLE OF MONTHS BACK. I HAVE TRIED SEVERAL NEEDLE CLIPPERS WITH POOR RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673692 BD SAFE-CLIP NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1