BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 11709157 · Received April 22, 2021

    Report

    Report Number
    1917413-2021-00312
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO GEL AIR BUBBLES AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR THE GEL AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO GEL AIR BUBBLES AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AIR BUBBLES WERE DISCOVERED IN GEL. THIS OCCURRED WITH 400 TUBES OF LOT# 0133206, 600 TUBES OF LOT# 0100176, 400 TUBES OF LOT# 0227164, 200 TUBES LOT# 0184330, AND 100 TUBES OF LOT# 0316256. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE,MANY PPT TUBES WERE GEL AIR BUBBLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AIR BUBBLES WERE DISCOVERED IN GEL. THIS OCCURRED WITH 400 TUBES OF LOT# 0133206, 600 TUBES OF LOT# 0100176, 400 TUBES OF LOT# 0227164, 200 TUBES LOT# 0184330, AND 100 TUBES OF LOT# 0316256. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE,MANY PPT TUBES WERE GEL AIR BUBBLES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0100176, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0227164, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0184330, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0316256, MEDICAL DEVICE EXPIRATION DATE: 2020-11-11, DEVICE MANUFACTURE DATE: (B)(6) 2021. 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 PRIOR TO USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AIR BUBBLES WERE DISCOVERED IN GEL. THIS OCCURRED WITH 400 TUBES OF LOT# 0133206, 600 TUBES OF LOT# 0100176, 400 TUBES OF LOT# 0227164, 200 TUBES LOT# 0184330, AND 100 TUBES OF LOT# 0316256. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEFORE USE,MANY PPT TUBES WERE GEL AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604857 BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 0133206 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1