BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 16261241 · Received January 28, 2023

    Report

    Report Number
    2243072-2023-00083
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 1, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPERS ARE COMING OUT OF TUBE DURING TRANSPORT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: EDTA TUBES ARE OPENING DURING TRANSPORTATION, SORTING, AND HOMOGENIZER, CUSTOMER REPORTS THEY ARE STILL FACING ISSUES WITH THE TUBES. D.1. MEDICAL DEVICE BRAND NAME: BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR; D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA. ¿ CURITIBA, BRAZIL / 81170-230; D.4 MEDICAL DEVICE CATALOG #: 360060; D.4. MEDICAL DEVICE LOT #: 2273595; D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2023; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1 MANUFACTURING LOCATION: BECTON DICKINSON IND. CIRURGICAS LTDA. ¿ CURITIBA, BRAZIL / 81170-230; G.5. PMA / 510(K)#: NA. H.4. DEVICE MANUFACTURE DATE: 08-NOV-2022. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY EVALUATED AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR STOPPER POP-OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPERS ARE COMING OUT OF TUBE DURING TRANSPORT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: EDTA TUBES ARE OPENING DURING TRANSPORTATION, SORTING, AND HOMOGENIZER, CUSTOMER REPORTS THEY ARE STILL FACING ISSUES WITH THE TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED BD BLOOD COLLECTION TUBES THE STOPPERS ARE COMING OUT OF TUBE DURING TRANSPORT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: EDTA TUBES ARE OPENING DURING TRANSPORTATION, SORTING, AND HOMOGENIZER, CUSTOMER REPORTS THEY ARE STILL FACING ISSUES WITH THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389238 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2273595

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown