BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS DISPOSAL

    MDR report key: 8901850 · Received August 16, 2019

    Report

    Report Number
    2243072-2019-01741
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, AND PMA/510(K)# HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SHARPS DISPOSALS EXPERIENCED AN INABILITY TO CLIP OR WAS JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BY FOLLOW-UP CALL, THE PATIENT'S MOTHER REPORTS THAT SINCE THE MONTH OF MAY / 2019 (DATE NOT EXACT) AND SO FAR, THE NEEDLE CUTTER IS NOT USEFUL SINCE SHE MENTIONS THAT THE NEEDLES DO NOT PASS OR ENTER THROUGH THE" HOLE " OF THE NEEDLE CUTTER. D.1. MEDICAL DEVICE BRAND NAME: SHARPS DISPOSAL; D.1. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE; D.2. MEDICAL DEVICE TYPE: FMI; D.4. MEDICAL DEVICE CATALOG #: 328235; D.4. MEDICAL DEVICE LOT #: 7177532; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.5. PMA/510(K)#: K943683; H.4. DEVICE MANUFACTURE DATE: 2017-07-14; H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.3 LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 6TH RELATED COMPLAINT FOR NOT CLIPPING (CUTTER BLOCKED) ON LOT # 7177532. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. ACCORDING WITH THE DHR REVIEW INFORMATION ATTACHED (SEE ATTACHED FILE), THE PROBLEM ¿NO CLIPPING¿,¿ CUTTER BLOCKED¿ AND ¿DIFFICULT OR UNABLE TO OPERATE¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (SAMPLE PLAN C=0, AQL=1). AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SHARPS DISPOSALS EXPERIENCED AN INABILITY TO CLIP OR WAS JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BY FOLLOW-UP CALL, THE PATIENT'S MOTHER REPORTS THAT SINCE THE MONTH OF MAY / 2019 (DATE NOT EXACT) AND SO FAR, THE NEEDLE CUTTER IS NOT USEFUL SINCE SHE MENTIONS THAT THE NEEDLES DO NOT PASS OR ENTER THROUGH THE" HOLE " OF THE NEEDLE CUTTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD SAFETY CLIPPING DEVICE EXPERIENCED AN INABILITY TO CLIP OR WAS JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BY FOLLOW-UP CALL, THE PATIENT'S MOTHER REPORTS THAT SINCE THE MONTH OF (B)(6)/ 2019 (DATE NOT EXACT) AND SO FAR, THE NEEDLE CUTTER IS NOT USEFUL SINCE SHE MENTIONS THAT THE NEEDLES DO NOT PASS OR ENTER THROUGH THE" HOLE " OF THE NEEDLE CUTTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. OEM MANUFACTURE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD SAFETY CLIPPING DEVICE EXPERIENCED AN INABILITY TO CLIP OR WAS JAMMED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BY FOLLOW-UP CALL, THE PATIENT'S MOTHER REPORTS THAT SINCE THE MONTH OF (B)(6) 2019 (DATE NOT EXACT) AND SO FAR, THE NEEDLE CUTTER IS NOT USEFUL SINCE SHE MENTIONS THAT THE NEEDLES DO NOT PASS OR ENTER THROUGH THE" HOLE " OF THE NEEDLE CUTTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696660 SHARPS DISPOSAL HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 7177532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other