BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SUREPATH¿ COLLECTION VIAL

    MDR report key: 16461258 · Received March 1, 2023

    Report

    Report Number
    1119779-2023-00188
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MKQ
    UDI-DI
    10382904914520
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2243486. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2025. DEVICE MANUFACTURE DATE: 31-AUG-2022. MEDICAL DEVICE LOT#: 2272505. MEDICAL DEVICE EXPIRATION DATE: 14-SEP-2025. DEVICE MANUFACTURE DATE: 29-SEP-2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: 12-MONTH COMPLAINT REVIEW WAS PERFORMED FOR THE ITEM NUMBER AND IDENTIFIED PREVIOUS COMPLAINTS FOR THE DEFECT MODE. NO PREVIOUS COMPLAINTS FOR THE DEFECT MODE WERE IDENTIFIED FOR THE LOT NUMBERS. MATERIAL 491452 IS MANUFACTURED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED FILLING LINE REFERRED TO AS THE SHIBUYA VIAL FILLING LINE. THE CAPPER SECTION OF THE SHIBUYA VIAL FILLING LINE CONTAINS EIGHT (8) CAPPER HEADS, WHICH CAPS THE VIALS TO A VALIDATED APPLICATION TORQUE RANGE, CONTROLLED BY SERVO MOTOR. THE CAPPER IS VALIDATED TO INSPECT FOR APPLICATION TORQUE AND UNSEATED OR MISSING CAPS. VIALS THAT FAIL TO MEET INSPECTION REQUIREMENTS ARE REJECTED AUTOMATICALLY AFTER THE CAPPER SECTION. TO ENSURE THAT THE CAPPER REMAINS IN VALIDATED STATE, A QUARTERLY PM IS ESTABLISHED THAT IS USED TO CONFIRM ACCURACY OF APPLICATION TORQUE FOR EACH OF THE CAPPER HEADS. THE PM IS PERFORMED BY USING A CALIBRATED SERVO TORQUE VERIFIER THAT IS COMPARED AGAINST THE SHIBUYA CAP APPLICATION TORQUE VALUE. PRODUCTION OF MATERIAL 491452 LOT 2243486 AND 2272505 STARTED ON 13SEP2022 AND 05OCT2022 RESPECTIVELY, WITH A TOTAL OF 432 KITS (216,000 VIALS) PRODUCED FOR EACH LOT. A REVIEW OF THE THREE (3) PM EVENTS THAT BRACKETED THE PRODUCTION DATES IDENTIFIED THAT THE RESULTS OF THE VERIFICATION WERE ACCEPTABLE. FURTHER REVIEW IDENTIFIED THAT THERE HAS NEVER BEEN A FAILURE OF THE SERVO TORQUE VERIFICATION PM EVENTS. THE REVIEW OF THE MANUFACTURING DHR FOR THE LOT NUMBERS IDENTIFIED THAT IT WAS COMPLETE AND ACCURATE DURING PRODUCTION AT THE MEBANE, NC FACILITY. DURING THE PRODUCTION PROCESS, A STATISTICAL SAMPLE OF VIALS WERE SUBJECT TO LEAK TESTING UNDER VACUUM. NO LEAKING VIALS WERE OBSERVED. NO PICTURES WERE PROVIDED; HOWEVER, THREE VIALS WERE RETURNED FROM LOT 2272505. THE VIALS RETURNED DID NOT LEAK AND NO ABNORMALITIES OF THE CAP OR VIAL WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. AN ANALYSIS OF THE RETAINS WAS PERFORMED AND DID NOT IDENTIFY ANY LEAKS OR ABNORMALITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SUREPATH¿ COLLECTION VIAL LEAKING WAS NOTICED AFTER SAMPLE COLLECTION. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VIALS LEAKING LOT#S 2243486 AND 2272505. THE ISSUE WAS NOTICED AFTER SAMPLE COLLECTION AND THE STAFF USING THE CONTAINERS DID NOT NOTICE ANY DAMAGE TO THE CONTAINERS. WE SUSPECTED THAT THE LIDS FOR THE CONTAINERS WERE NOT BEING SCREWED ON TIGHTLY WHICH IS CAUSING THE LEAKAGE TO OCCUR, BUT UPON INVESTIGATING THE ISSUE FURTHER, WE NOTICED IT WAS NOT POSSIBLE TO SCREW THE LIDS ON TIGHTLY TO PREVENT THE LEAKING WITHOUT RUNNING THE RISK OF THE LID POPPING OFF ENTIRELY WHEN IT IS SCREWED ON TIGHTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SUREPATH¿ COLLECTION VIAL LEAKING WAS NOTICED AFTER SAMPLE COLLECTION. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VIALS LEAKING LOT#S 2243486 AND 2272505. THE ISSUE WAS NOTICED AFTER SAMPLE COLLECTION AND THE STAFF USING THE CONTAINERS DID NOT NOTICE ANY DAMAGE TO THE CONTAINERS. WE SUSPECTED THAT THE LIDS FOR THE CONTAINERS WERE NOT BEING SCREWED ON TIGHTLY WHICH IS CAUSING THE LEAKAGE TO OCCUR, BUT UPON INVESTIGATING THE ISSUE FURTHER, WE NOTICED IT WAS NOT POSSIBLE TO SCREW THE LIDS ON TIGHTLY TO PREVENT THE LEAKING WITHOUT RUNNING THE RISK OF THE LID POPPING OFF ENTIRELY WHEN IT IS SCREWED ON TIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196832 BD SUREPATH¿ COLLECTION VIAL PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ BECTON, DICKINSON & CO. (SPARKS) 491452 SEE H.10 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown