BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 2ML SYRINGE

    MDR report key: 12650566 · Received October 18, 2021

    Report

    Report Number
    3002682307-2021-00557
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    June 10, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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

    H.6. INVESTIGATION: A COMPLAINT OF DAMAGE FOUND ON A SYRINGE CAUSING LEAKAGE WAS RECEIVED BY THE CUSTOMER. THIS IS THE 1ST COMPLAINT FOR LEAKAGE ON MATERIAL 300727 AND BATCH 2103129. NO PHOTOS OR SAMPLES WERE RETURNED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 2103277. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD EMERALD¿ 2ML SYRINGES EXPERIENCED DAMAGED SYRINGE TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE ADMINISTRATION OF THE RADIOPHARMACEUTICAL, A DROP OF BLOOD APPEARED ON THE PAD (THIS IS ABNORMAL BECAUSE ONCE THE SYRINGE HAS BEEN CONNECTED TO THE TUBING, THERE SHOULD BE NO LEAKAGE). THE ADMINISTRATION OF THE DRUG WAS STOPPED AND THE RESIDUAL ACTIVITY IN THE SYRINGE WAS CHECKED: ONLY 20% OF THE INITIALLY PLANNED ACTIVITY HAS BEEN ADMINISTERED (147 MBQ OUT OF THE 750 MBQ). (147 MBQ OUT OF THE 750MBQ) NO TEAM MEMBER HAD DIRECT CONTACT WITH BLOOD OR THE PRODUCT USED. THE LEAK IS DIFFICULT TO SEE WITH THE NAKED EYE, BUT APPEARS TO BE A PHYSICAL DEFECT IN THE SYRINGE: THE CHIP IS ABOUT 1MM IN SIZE AND IS LOCATED ON THE END OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2103129. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-03-01. MEDICAL DEVICE LOT #: 103277 MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-03-22.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD EMERALD¿ 2ML SYRINGES EXPERIENCED DAMAGED SYRINGE TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE ADMINISTRATION OF THE RADIOPHARMACEUTICAL, A DROP OF BLOOD APPEARED ON THE PAD (THIS IS ABNORMAL BECAUSE ONCE THE SYRINGE HAS BEEN CONNECTED TO THE TUBING, THERE SHOULD BE NO LEAKAGE). THE ADMINISTRATION OF THE DRUG WAS STOPPED AND THE RESIDUAL ACTIVITY IN THE SYRINGE WAS CHECKED: ONLY 20% OF THE INITIALLY PLANNED ACTIVITY HAS BEEN ADMINISTERED (147 MBQ OUT OF THE 750 MBQ). (147 MBQ OUT OF THE 750MBQ) NO TEAM MEMBER HAD DIRECT CONTACT WITH BLOOD OR THE PRODUCT USED. THE LEAK IS DIFFICULT TO SEE WITH THE NAKED EYE, BUT APPEARS TO BE A PHYSICAL DEFECT IN THE SYRINGE: THE CHIP IS ABOUT 1MM IN SIZE AND IS LOCATED ON THE END OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548640 BD EMERALD¿ 2ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2103277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown