BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10646329 · Received October 7, 2020

    Report

    Report Number
    2243072-2020-01594
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 17, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-01. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) USED BD SAFE CLIP DEVICE FROM LOT 7285551. CONSUMER REPORTED HIS SAFE CLIP IS STILL CLIPPING, BUT IT IS HARD TO OPEN. THE RETURNED SAFE CLIP WAS EXAMINED, THEN TESTED BY CLIPPING 3 TEST CANNULA: THE SAFE CLIP WAS ABLE TO OPEN AND CLIP CANNULA PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. ACCORDING WITH THE DHR REVIEW INFORMATION ATTACHED, 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HIS SAFE CLIP IS HARD TO USE. STATED HE HAS USED IT 2 DOZEN TIMES AND IT IS STILL CLIPPING, BUT IT IS HARD TO OPEN. STATED HE HAS TO OPEN IT MANUALLY. LOT #: 7285551. CATALOG#: 328235. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: (B)(4). 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 AN UNSPECIFIED NUMBER OF BD SAFE-CLIPS¿ EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HIS SAFE CLIP IS HARD TO USE. STATED HE HAS USED IT 2 DOZEN TIMES AND IT IS STILL CLIPPING, BUT IT IS HARD TO OPEN. STATED HE HAS TO OPEN IT MANUALLY. LOT #: 7285551, CATALOG#: 328235, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104977 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 7285551 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other