BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 8781484 · Received July 11, 2019

    Report

    Report Number
    1024879-2019-01166
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR AN EXTRA SLEEVE AND BENT NP NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND BOTH AN EXTRA SLEEVE AND BENT NP NEEDLE WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMITIES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODES FOR AN EXTRA SLEEVE AND BENT NP NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND AN EXTRA SLEEVE AND BENT NP NEEDLE WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER FROM LOT# 8101988 HAD AN INCORRECTLY PLACED SLEEVE THAT WAS CAUGHT IN THE SHIELD, AND 1 LUER ADAPTER FROM LOT# 8108991 HAD A BENT NON-PATIENT END NEEDLE. BOTH DEFECTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "EXTRA SLEEVE. NP NEEDLE BENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8101988, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2018-04-11. MEDICAL DEVICE LOT #: 8108991, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-04-18. 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 1 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER FROM LOT# 8101988 HAD AN INCORRECTLY PLACED SLEEVE THAT WAS CAUGHT IN THE SHIELD, AND 1 LUER ADAPTER FROM LOT# 8108991 HAD A BENT NON-PATIENT END NEEDLE. BOTH DEFECTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "EXTRA SLEEVE. NP NEEDLE BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576397 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other