BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 7692887 · Received July 17, 2018

    Report

    Report Number
    2243072-2018-00490
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 21, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: B.5.THE EVENT OR PROBLEM DESCRIPTION IS CORRECTED TO: IT WAS REPORTED THAT THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD SOMETHING IN THE GEL THAT INTERFERED WITH TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. D.1. MEDICAL DEVICE BRAND NAME IS CORRECTED TO BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG. D.3. MEDICAL DEVICE MANUFACTURER IS CORRECTED TO BROKEN BOW. D.4. UNIQUE IDENTIFIER (UDI) # IS CORRECTED TO (B)(4). D.4. MEDICAL DEVICE LOT # IS CORRECTED TO 362788. D.4. MEDICAL DEVICE BATCH # IS CORRECTED TO 7340673. D.4. MEDICAL DEVICE EXPIRATION DATE IS CORRECTED TO 12/31/2018. G. 1. MANUFACTURING LOCATION IS CORRECTED TO BROKEN BOW. G.5. PMA / 510(K)# IS CORRECTED TO K972075 . H.4. DEVICE MANUFACTURE DATE IS CORRECTED TO 12/06/2017. DUE TO AN IT ISSUE BEGINNING ON (B)(6)2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: NO.

    Additional Manufacturer Narrative · 0

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAD FOLLOWED UP WITH THE CUSTOMER AND DETERMINED THAT THE ISSUE (AS STATED BY THE CUSTOMER) WAS SPECIFIC TO A PARTICULAR LOT OF INSTRUMENT CARTRIDGE AND THE PPT TUBE TYPE WAS NOT CORRECTLY VALIDATED ON THIS INSTRUMENT. FURTHERMORE, THE CONCERN HAS NOT BEEN SEEN AGAIN SINCE A NEW CARTRIDGE LOT WAS PLACED IN USE. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. BD HAD FOLLOWED UP WITH THE CUSTOMER AND DETERMINED THAT THE ISSUE (AS STATED BY THE CUSTOMER) WAS SPECIFIC TO A PARTICULAR LOT OF INSTRUMENT CARTRIDGE AND THE PPT TUBE TYPE WAS NOT CORRECTLY VALIDATED ON THIS INSTRUMENT. FURTHERMORE, THE CONCERN HAS NOT BEEN SEEN AGAIN SINCE A NEW CARTRIDGE LOT WAS PLACED IN USE. 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 THAT THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD SOMETHING IN THE GEL THAT INTERFERED WITH TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD VACUTAINER PRODUCT HAD SOMETHING IN THE GEL THAT INTERFERED WITH TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE UNSPECIFIED BD VACUTAINER® PRODUCT HAD SOMETHING IN THE GEL THAT INTERFERED WITH TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538104 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7340673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other