BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    MDR report key: 10900218 · Received November 25, 2020

    Report

    Report Number
    3003916417-2020-00344
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 4, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.1. MEDICAL DEVICE BRAND NAME: BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. D.1 MEDICAL DEVICE TYPE: JKA. D.2. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE PHOTOS WERE REVIEWED AND COLOR VARIATION BETWEEN THE TUBES SHOWN WAS OBSERVED BUT THE SLIGHT VARIATION IN THE COLOR OF THE HEMOGARD SHIELDS ARE WITHIN ACCEPTABLE MANUFACTURING REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPERS HAVE COLOR VARIATIONS WITH A BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. THIS OCCURRED WITH 1498 TUBES WITH THE UNSPECIFIED LOT#. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: (1 OF 2 COMPLAINTS). COMPLAINT ABOUT THE YELLOW HUE OF THE STOPPERS OF ITEM 360059. THE CLIENT HAS REPORTED THAT THE GEL TUBE STOPPERS 360059 (NATIONAL) AND 367983 (IMPORTED) ARE IN DIFFERENT SHADES OF YELLOW AND THE PVP TUBE SORTING DEVICE (ROCHE) IS NOT IDENTIFYING A GOOD PART OF THEM. 1500 TUBES/DAY ARE BEING SEPARATED MANUALLY, CAUSING INCONVENIENCE TO THE CUSTOMER. INFO ADD OBTAINED WITH THE SALES EXECUTIVE: THE COLOR VARIATION OCCURS BETWEEN THE TUBES OF THE DIFFERENT CATALOGS (360059 & 367983) AND THERE IS ALSO A DIVERGENCE BETWEEN THE STOPPERS OF THE SAME CATALOG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPERS HAVE COLOR VARIATIONS WITH A BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. THIS OCCURRED WITH 1498 TUBES WITH THE UNSPECIFIED LOT#. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: (1 OF 2 COMPLAINTS). COMPLAINT ABOUT THE YELLOW HUE OF THE STOPPERS OF ITEM 360059. THE CLIENT HAS REPORTED THAT THE GEL TUBE STOPPERS 360059 (NATIONAL) AND 367983 (IMPORTED) ARE IN DIFFERENT SHADES OF YELLOW AND THE PVP TUBE SORTING DEVICE (ROCHE) IS NOT IDENTIFYING A GOOD PART OF THEM. (B)(4) TUBES/DAY ARE BEING SEPARATED MANUALLY, CAUSING INCONVENIENCE TO THE CUSTOMER. INFO ADD OBTAINED WITH THE SALES EXECUTIVE: THE COLOR VARIATION OCCURS BETWEEN THE TUBES OF THE DIFFERENT CATALOGS (360059 & 367983) AND THERE IS ALSO A DIVERGENCE BETWEEN THE STOPPERS OF THE SAME CATALOG.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0244557; MEDICAL DEVICE EXPIRATION DATE: 2021-08-31; DEVICE MANUFACTURE DATE: 2020-09-23. MEDICAL DEVICE LOT #: 0244558; MEDICAL DEVICE EXPIRATION DATE: 2021-08-31; DEVICE MANUFACTURE DATE: 2020-09-23. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS HAVE COLOR VARIATIONS WITH A BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. THIS OCCURRED WITH 1498 TUBES WITH AN UNSPECIFIED LOT#. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: (1 OF 2 COMPLAINTS) COMPLAINT ABOUT THE YELLOW HUE OF THE STOPPERS OF ITEM 360059. THE CLIENT HAS REPORTED THAT THE GEL TUBE STOPPERS 360059 (NATIONAL) AND 367983 (IMPORTED) ARE IN DIFFERENT SHADES OF YELLOW AND THE PVP TUBE SORTING DEVICE (ROCHE) IS NOT IDENTIFYING A GOOD PART OF THEM. 1500 TUBES/DAY ARE BEING SEPARATED MANUALLY, CAUSING INCONVENIENCE TO THE CUSTOMER. INFO ADD OBTAINED WITH THE SALES EXECUTIVE: THE COLOR VARIATION OCCURS BETWEEN THE TUBES OF THE DIFFERENT CATALOGS (360059 & 367983) AND THERE IS ALSO A DIVERGENCE BETWEEN THE STOPPERS OF THE SAME CATALOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364354 BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1