BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 11720940 · Received April 23, 2021

    Report

    Report Number
    2243072-2021-01253
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SAFECLIP. THERE IS NO EXTERNAL DAMAGE, BUT THE PORT FOR NEEDLES TO BE PLACED IN AND CLIPPED HAS BECOME CLOGGED WITH METAL FRAGMENTS, MOST LIKELY OTHER NEEDLES. WHEN SHAKEN, NUMEROUS OTHER TRIMMED NEEDLES CAN BE HEARD INSIDE. FROM OBSERVATIONS, THE DEVICE MAY HAVE BECOME CLOGGED DURING REGULAR USE AFTER NUMEROUS USES. 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, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE DEVICE NOT CLIPPING DUE TO A JAM. THE ROOT CAUSE OF THE DEVICE BEING JAMMED IS MOST LIKELY NEEDLE DEBRIS OBSTRUCTING THE PORT OF THE DEVICE AFTER NUMEROUS NEEDLES WERE CLIPPED BY THE DEVICE OVER THE COURSE OF ITS LIFETIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE CLIPPING DEVICE SAFE CLIP WAS NOT CLIPPING NEEDLES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAFETY CLIP NEEDLE CLIPPER IS NO LONGER CLIPPING THE NEEDLES. VERBATIM: CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER IS NO LONGER CLIPPING THE NEEDLES. SHE SAID SHE PURCHASED IT IN NOVEMBER OF 2020 AND SHE KNOWS THAT IT IS NOT FULL BUT IT WILL NOT CLIP. LOT #: 0010001. CATALOG #: 328235. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO. 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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE CLIPPING DEVICE SAFE CLIP WAS NOT CLIPPING NEEDLES DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAFETY CLIP NEEDLE CLIPPER IS NO LONGER CLIPPING THE NEEDLES. VERBATIM: CONSUMER REPORTED THAT HER SAFE CLIP NEEDLE CLIPPER IS NO LONGER CLIPPING THE NEEDLES. SHE SAID SHE PURCHASED IT IN NOVEMBER OF 2020 AND SHE KNOWS THAT IT IS NOT FULL BUT IT WILL NOT CLIP.LOT #: 0010001CATALOG #: 328235DATE OF EVENT: UNKNOWNSAMPLES: AVAILABLE - SENDING MAIL KIT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611642 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 0010001 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1