BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1

    MDR report key: 13459054 · Received February 4, 2022

    Report

    Report Number
    2243072-2022-00155
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 24, 2022
    Report Date
    February 22, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF A DISCARDIT 5ML FROM LOT # 1222176 REGARDING ITEM # 301285 WITH THE REPORTED ISSUE THAT THE ¿SYRINGE WAS CRACKED¿. THE DHR OF MATERIAL NUMBER 301285 WITH BATCH NUMBER 1222176 WAS CHECKED AND THERE WERE NO QUALITY NOTIFICATIONS FOUND ON THIS LOT NUMBER. NO SAMPLES AND THREE PHOTOGRAPHS WERE RECEIVED FROM THE CUSTOMER ALONG WITH THE COMPLAINT. THE INVESTIGATING TEAM HAS ALSO USED THE RETENTION SAMPLES OF MATERIAL NUMBER 301285 AND LOT NUMBER 1222176 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR EMPTY POUCH AND NO EMPTY POUCH WAS FOUND IN THE TEN RETENTION SAMPLES. BASED ON THE PHOTOGRAPH THE DEFECT IS CONFIRMED. THE CRACKING OF THE BARREL WAS OBSERVED WHILE SIMULATING THIS PROCESS. IT WAS FOUND THAT WHEN COLD BARRELS (STORED IN POLY) ARE MIXED ALONG WITH ONLINE BARRELS, THERE IS A TEMPERATURE VARIATION OF HOT AND COLD BARRELS AS THEY ARE PASSING THROUGH THE PNEUMATIC SHOOT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 2 PC 5 ML SYRINGE - DISCARD IT II 22G×1 THE BARREL OF THE SYRINGE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PHLEBOTOMIST HAS OPENED THE PACK OF DISCARDIT 5ML 22G SYRINGE HE FOUND THAT BARREL OF THE SYRINGE WAS CRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1 THE BARREL OF THE SYRINGE WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PHLEBOTOMIST HAS OPENED THE PACK OF DISCARDIT 5ML 22G SYRINGE HE FOUND THAT BARREL OF THE SYRINGE WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561846 BD 2 PC 5 ML SYRINGE - DISCARDIT II 22G×1 PISTON SYRINGE FMF BECTON DICKINSON 1222176

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown