BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® SST¿ TUBES

    MDR report key: 8305364 · Received February 5, 2019

    Report

    Report Number
    2618282-2019-00122
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 28, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS IDENTIFIED A TUBE SHOWING LOT NUMBER 8072836 APART FROM AN OUTER POLYBAG SHOWING LOT 8086517. ADDITIONALLY, RETENTION SAMPLES OF BOTH INCIDENT LOT NUMBERS WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO THE LABELLING ON BOTH THE TUBES OR POLYBAGS WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR BOTH INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. LOT 8072836 WAS MANUFACTURED FROM 18-MAR-2018 TO 19-MAR-2018. THE EXPIRATION DATE FOR THIS LOT IS 31-MAY-2019. RETAIN EVALUATION: THE LABELLING WAS VERIFIED TO CONTAIN THE CORRECT LOT INFORMATION ON BOTH THE TUBE AND OUTER POLYBAG. LOT 8086517 WAS MANUFACTURED FROM 10-APR-2018 TO 11-APR-2018. THE EXPIRATION DATE FOR THIS LOT IS 30-JUN-2019. RETAIN EVALUATION: THE LABELLING WAS VERIFIED TO CONTAIN THE CORRECT LOT INFORMATION ON BOTH THE TUBE AND OUTER POLYBAG. BASED ON THE DATE OF MANUFACTURE FOR THE TWO LOTS, IT WAS NOTED THAT THEY WERE PRODUCED 23 DAYS APART AND THEREFORE, BASED ON THE CURRENT PRODUCTION CRITERIA AND LINE CLEARANCE PROCEDURES IN PLACE, THE OPPORTUNITY FOR THE TWO LOTS TO BE MIXED OR MISPRINTED DURING MANUFACTURING IS CONSIDERED REMOTE. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE RETENTION SAMPLES THE CUSTOMER¿S INDICATED FAILURE MODE FOR MIXED PRODUCT/LABELLING WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICROTAINER® SST¿ TUBES THERE WAS AN ISSUE WITH INCONSISTENT LOT NUMBER AND EXPIRY DATE ON OUTSIDE AND INSIDE OF PACKAGING. THE 200 TUBES INSIDE SAY LOT 8072836 AND THE PACKAGING SAYS LOT 8086517.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8072836; MEDICAL DEVICE EXPIRATION DATE: 2019-05-31; DEVICE MANUFACTURE DATE: 2018-03-13; MEDICAL DEVICE LOT #: 8086517; MEDICAL DEVICE EXPIRATION DATE: 2019-06-30; DEVICE MANUFACTURE DATE: 2018-03-27. DATE OF EVENT: UNKNOWN. (B)(6). 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 WITH THE USE OF THE BD MICROTAINER® SST¿ TUBES THERE WAS AN ISSUE WITH INCONSISTENT LOT NUMBER AND EXPIRY DATE ON OUTSIDE AND INSIDE OF PACKAGING. THE 200 TUBES INSIDE SAY LOT 8072836 AND THE PACKAGING SAYS LOT 8086517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102022 BD MICROTAINER® SST¿ TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other