BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 8842455 · Received July 30, 2019

    Report

    Report Number
    2243072-2019-01532
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED LOT#. THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.2. MEDICAL DEVICE LOT#: 5082356. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. H.4. DEVICE MANUFACTURE DATE: 2015-05-07, H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) BD BLUE/BLACK SAFE-CLIP FROM LOT # 5082356. CUSTOMER STATES THAT THE DEVICE WAS NOT CLIPPING NEEDLES CLEANLY. RETURNED SAFE CLIP WAS EXAMINED UNDER THE MICROSCOPE AND THE CUTTING HOLE APPEARED CLEAR. THE SAFE CLIP WAS TESTED AND WAS ABLE TO SUCCESSFULLY CUT NEEDLES WITHOUT ANY OBSERVED DEFECTS. A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER'S BRAND NEW NEEDLE CLIPPING DEVICE SAFE CLIP WOULD NOT CLIP THROUGH NEEDLES CLEANLY DURING USE AFTER THE "FIRST INITIAL CLIPS", HAVING TO TWIST THE PEN NEEDLE IN ORDER TO CLIP THEM, OR RELEASING THE DEVICE AND RE-CLIPPING. THE CONSUMER ALSO REPORTED THAT THE HOLES WOULDN'T LINE UP WITH THE INSERTED NEEDLE AUTOMATICALLY, AND THE DEVICE HAD TO BE OPENED AND CLOSED "A COUPLE OF TIMES" BEFORE SUCCESSFULLY LINING UP THE HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PHONED THROUGH VIA CUSTOMER SERVICE. HAS JUST RETURNED FROM 7 WEEK HOLIDAY OVERSEAS. TOOK BRAND NEW SAFECLIP AWAY WITH HIM GIVEN PERIOD WAS GOING TO BE TRAVELLING. AFTER FIRST INITIAL CLIPS, FOUND THAT DEVICE WAS NOT CLIPPING NEEDLES CLEANLY, INSTEAD THE PEN DEVICE NEEDED TO BE TWISTED FOR NEEDLE TO BE CLIPPED OR DEVICE HAD TO BE RELEASED AND RE-CLIPPED A COUPLE OF TIMES BEFORE NEEDLE WAS CLIPPED. ALSO FOUND THAT HOLES WHERE NEEDLE IS INSERTED WOULDN'T LINE UP AUTOMATICALLY AND DEVICE NEEDED TO BE OPEN & CLOSED A COUPLE OF TIMES BEFORE HOLES WOULD LINE UP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER'S BRAND NEW NEEDLE CLIPPING DEVICE SAFE CLIP WOULD NOT CLIP THROUGH NEEDLES CLEANLY DURING USE AFTER THE "FIRST INITIAL CLIPS", HAVING TO TWIST THE PEN NEEDLE IN ORDER TO CLIP THEM, OR RELEASING THE DEVICE AND RE-CLIPPING. THE CONSUMER ALSO REPORTED THAT THE HOLES WOULDN'T LINE UP WITH THE INSERTED NEEDLE AUTOMATICALLY, AND THE DEVICE HAD TO BE OPENED AND CLOSED "A COUPLE OF TIMES" BEFORE SUCCESSFULLY LINING UP THE HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PHONED THROUGH VIA CUSTOMER SERVICE. HAS JUST RETURNED FROM 7 WEEK HOLIDAY OVERSEAS. TOOK BRAND NEW SAFECLIP AWAY WITH HIM GIVEN PERIOD WAS GOING TO BE TRAVELLING. AFTER FIRST INITIAL CLIPS, FOUND THAT DEVICE WAS NOT CLIPPING NEEDLES CLEANLY, INSTEAD THE PEN DEVICE NEEDED TO BE TWISTED FOR NEEDLE TO BE CLIPPED OR DEVICE HAD TO BE RELEASED AND RE-CLIPPED A COUPLE OF TIMES BEFORE NEEDLE WAS CLIPPED. ALSO FOUND THAT HOLES WHERE NEEDLE IS INSERTED WOULDN'T LINE UP AUTOMATICALLY AND DEVICE NEEDED TO BE OPEN & CLOSED A COUPLE OF TIMES BEFORE HOLES WOULD LINE UP."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE CONSUMER'S BRAND NEW NEEDLE CLIPPING DEVICE SAFE CLIP WOULD NOT CLIP THROUGH NEEDLES CLEANLY DURING USE AFTER THE "FIRST INITIAL CLIPS", HAVING TO TWIST THE PEN NEEDLE IN ORDER TO CLIP THEM, OR RELEASING THE DEVICE AND RE-CLIPPING. THE CONSUMER ALSO REPORTED THAT THE HOLES WOULDN'T LINE UP WITH THE INSERTED NEEDLE AUTOMATICALLY, AND THE DEVICE HAD TO BE OPENED AND CLOSED "A COUPLE OF TIMES" BEFORE SUCCESSFULLY LINING UP THE HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT PHONED THROUGH VIA CUSTOMER SERVICE. HAS JUST RETURNED FROM 7 WEEK HOLIDAY OVERSEAS. TOOK BRAND NEW SAFE CLIP AWAY WITH HIM GIVEN PERIOD WAS GOING TO BE TRAVELLING. AFTER FIRST INITIAL CLIPS, FOUND THAT DEVICE WAS NOT CLIPPING NEEDLES CLEANLY, INSTEAD THE PEN DEVICE NEEDED TO BE TWISTED FOR NEEDLE TO BE CLIPPED OR DEVICE HAD TO BE RELEASED AND RE-CLIPPED A COUPLE OF TIMES BEFORE NEEDLE WAS CLIPPED. ALSO FOUND THAT HOLES WHERE NEEDLE IS INSERTED WOULDN'T LINE UP AUTOMATICALLY AND DEVICE NEEDED TO BE OPEN & CLOSED A COUPLE OF TIMES BEFORE HOLES WOULD LINE UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634281 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON 5082356 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other