BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 19260799 · Received May 7, 2024

    Report

    Report Number
    3002682307-2024-00096
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220610. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. ALTHOUGH A SAMPLE SHIPMENT WAS ARRANGED, WE UNFORTUNATELY HAVE BEEN UNABLE TO LOCATE THE RETURNED SAMPLES AT THIS TIME. WE APOLOGIZE FOR THE INCONVENIENCE. IF THE SAMPLES ARE LOCATED, A THOROUGH ANALYSIS WILL BE PERFORMED. RETAINED SAMPLES WERE UTILIZED AT THIS TIME FOR FURTHER EVALUATION. TWENTY (20) RETAINED SAMPLES OF LOT NUMBER 220610 WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED NEEDLES WERE ASSEMBLED WITH A BD EMERALD 2ML SYRINGE USING REGULAR PRACTICES. THE NEEDLE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED SAMPLES PRESENTED ANY DEFECT AND NO DIFFICULTIES WERE NOTED DURING THE ASSEMBLY PROCESS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. PER THE PROVIDED FEEDBACK, WE UNDERSTAND AN ISSUE OF DEFECTIVE HUB CONNECTION TOOK PLACE. IT IS POSSIBLE FOR THIS DEFECT TO RESULT DUE TO DEFECTIVE LUER DIMENSIONS, DAMAGE IN THE SYRINGE TIP, OR AN INSUFFICIENT ADJUSTMENT BETWEEN THE DEVICES DURING USE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220610. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES OF REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EVALUATED; THE NEEDLE WAS ASSEMBLED WITH A BD EMERALD 2 ML SYRINGE BY FOLLOWING THE INSTRUCTIONS AND POSITIONING THE HUB ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NO SIGNS OF DEFECTIVE HUB CONNECTION OR LEAKAGE WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. PER THE PROVIDED FEEDBACK, WE UNDERSTAND A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE. IT IS POSSIBLE THAT THE REPORTED ISSUE RESULTED FROM DEFECTIVE LUER DIMENSIONS OR DAMAGE IN THE SYRINGE TIP OR FROM AN INSUFFICIENT ADJUSTMENT BETWEEN THE DEVICES BY THE END USER. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 30GA 1/2IN HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: WE WOULD LIKE TO INFORM YOU THAT WE HAVE RECEIVED A CUSTOMER COMPLAINT CONCERNING A NEEDLE QUALITY PROBLEM ("INJECTING THE LIQUID DETACHED THE NEEDLE FROM THE CONTAINER WHERE THE LIQUID GOES AND ALL THE LIQUID SPILLED."). BATCH OF 30G NEEDLES AFFECTED: 220800156 (SUPPLIER BATCH: 220610, REFERENCE: 304000); THIS IS THE 2ND COMPLAINT AFFECTING THIS BATCH OF NEEDLES. ADDITIONAL INFORMATION PROVIDED TRANSLATED FROM FRENCH TO ENGLISH: ¿ WAS THERE AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, NECESSARY CHANGE IN TREATMENT)? THE PATIENT WAS UNABLE TO INJECT THE DOSE OF PRODUCT ¿ HAVE HEALTH PERSONNEL BEEN EXPOSED TO BLOOD OR BODILY FLUIDS? NO ¿ COULD YOU CONFIRM THE TYPE OF LIQUID USED? CAVERJECT RECONSTITUTED SOLUTION ¿ COULD YOU SPECIFY IF THESE ARE SAMPLES: SAMPLE USED BUT NOT AVAILABLE TO DATE O NOT USED (BEFORE USE) O USED (DURING OR AFTER USE) ¿ IMPORTANT: IF USED, PLEASE CONFIRM WHETHER SAMPLES HAVE BEEN USED OR ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. ¿ PLEASE ALSO TELL US THE FULL COLLECTION ADDRESS, CONTACT PERSON NAME AND NUMBER, DEPARTMENT NAME, FLOOR NUMBER AND ANY OTHER ADDITIONAL DETAILS SUCH AS (COLLECTION AT RECEPTION, GOODS IN THE YARD, ETC.) AND WE WILL SCHEDULE A SAMPLE PICKUP REQUEST FOR YOU USING THE TNT CARRIER. ¿ CAN YOU PROVIDE PHOTOGRAPHS OF THE PRODUCT CONCERNED, REPRESENTATIVE OF THE REPORTED DEFECT? NO PHOTO AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382104 BD NEEDLE 30GA 1/2IN NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 220610 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown