BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 10237750 · Received July 6, 2020

    Report

    Report Number
    2243072-2020-01007
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 7/13/2020 H.6. INVESTIGATION: CUSTOMER RETURNED THREE (3) USED BD SAFECLIP DEVICES FROM LOTS 9189034, 6221064, AND 2172223. CUSTOMER REPORTED THAT SAFE CLIPS ARE NOT CLIPPING AFTER ONLY A FEW NEEDLES AND THEY ARE JAMMED. ALL THREE RETURNED SAFE-CLIP DEVICES WERE EXAMINED MICROSCOPICALLY AND ALL THREE CUTTING HOLES WERE OBSERVED TO BE BLOCKED BY CANNULA CUT FROM PREVIOUS USAGE. CANNULA WERE NOT ABLE TO BE CUT USING THE THREE RETURNED SAFE-CLIP DEVICES. THE MOST LIKELY SCENARIO IS THAT THE SAFE-CLIPS ARE FULL, HAVE BEEN USED OVER TIME, AND THERE IS NO ROOM TO STORE ADDITIONAL CANNULA. THIS 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 ATTACHED FOR LOTS 9189034 AND 2172223, THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0 AND AQL=1). AS PER MANUFACTURING: A DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 6221064 WAS MANUFACTURED IN 2007 (13 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 NEEDLE CLIPPING DEVICE SAFE CLIP FROM LOT# 9189034, 1 SAFECLIP FROM LOT# 2172223, AND 1 SAFECLIP FROM AN UNSPECIFIED LOT JAMMED DURING USE AFTER CLIPPING "JUST A FEW NEEDLES". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT HIS SAFE CLIP NEEDLE CLIPPERS JAM WHEN HE TRIES TO CLIP THE NEEDLES. ISSUE INVOLVES 3 NEEDLE CLIPPERS. I RETURNED CONSUMER'S CALL, HE PROVIDED ADDITIONAL INFORMATION AND STATED THAT THE NEEDLE CLIPPERS JAM AFTER CLIPPING JUST A FEW NEEDLES."

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9189034, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2019-07-24, MEDICAL DEVICE LOT #: 2172223, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2012-07-09, MEDICAL DEVICE LOT #: UNKNOWN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 NEEDLE CLIPPING DEVICE SAFE CLIP FROM LOT# 9189034, 1 SAFECLIP FROM LOT# 2172223, AND 1 SAFECLIP FROM AN UNSPECIFIED LOT JAMMED DURING USE AFTER CLIPPING "JUST A FEW NEEDLES". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT HIS SAFE CLIP NEEDLE CLIPPERS JAM WHEN HE TRIES TO CLIP THE NEEDLES. ISSUE INVOLVES 3 NEEDLE CLIPPERS. I RETURNED CONSUMER'S CALL, HE PROVIDED ADDITIONAL INFORMATION AND STATED THAT THE NEEDLE CLIPPERS JAM AFTER CLIPPING JUST A FEW NEEDLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696442 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 SEE SECTION H.10. 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other