BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE

    MDR report key: 8255852 · Received January 17, 2019

    Report

    Report Number
    3002682307-2018-00356
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 27, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- 180414: NEEDLES WERE PACKED IN MACHINE Nº2101 (APRIL 07-10TH, 2018) DURING WHICH 62 VISUAL INSPECTION OF 100 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES (#8082596) WERE ASSEMBLED IN MACHINE Nº 4411 (APRIL 03-08TH, 2018) DURING WHICH 188 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH 0 REJECTION NOTED. CANNULA BATCHES: 8017960, 7352916 AND 8045567. 180702: NEEDLES WERE PACKED IN MACHINE Nº2101 (JULY 09-12ND, 2018) DURING WHICH 69 VISUAL INSPECTION OF 100 UNITS EACH WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE Nº 4412 AND COME FORM 3 BATCHES: #8165798 (JUNE 19-23RD, 2018) DURING WHICH 198 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH 0 REJECTION NOTED. #8176533 (JULY 09-11ST, 2018) DURING WHICH 96 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH 0 REJECTION NOTED. #8141680 (MAY 26-28TH, 2018) DURING WHICH 84 VISUAL INSPECTION OF 25 UNITS EACH WERE CARRIED OUT WITH 0 REJECTION NOTED. CANNULA BATCHES: 8114821, 8045567 AND 8143920. BD HAS BEEN PROVIDED WITH TEN REFERENCE SAMPLES OF LOT 180702 AND THE AFFECTED SAMPLE. VISUAL INSPECTION OF AFFECTED SAMPLE SHOW A BROKEN CANNULA AT THE LEVEL OF THE HUB AND EXAMINATION UNDER MICROSCOPE REVEAL CANNULA WAS BENT PRIOR TO BREAK. PULL CANNULA TESTS WERE PERFORMED IN THE REFERENCE SAMPLES AND IT SHOWS REALLY HIGH VALUES OF CANNULA PULL FORCE (AVERAGE 24.20KG, SPEC.4.54KG). BASED ON ABOVE RESULTS, BD CONFIRMS THE REPORTED ISSUE YOUR INDICATED FAILURE MODE. SINCE REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, REFERENCE SAMPLES RESULTS WERE WITHIN SPECIFICATION AND EXAMINATION OF RETURNED AFFECTED SAMPLE, BD DETERMINES THE BREAKAGE¿S ROOT CAUSE IS RELATED TO THE HANDLING OF THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ NEEDLE WAS DETACHED FROM NEEDLE HUB, WHEN NEEDLE WAS REMOVED FROM THE VEIN OF A CALF. THERE WERE TOTAL THREE SIMILAR INCIDENTS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 180702, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2018-06-19. MEDICAL DEVICE LOT #: 180414, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2018-04-04. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ NEEDLE WAS DETACHED FROM NEEDLE HUB, WHEN NEEDLE WAS REMOVED FROM THE VEIN OF A CALF. THERE WERE TOTAL THREE SIMILAR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49408 BD¿ NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other