BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT® BPN CULTURE BOTTLE

    MDR report key: 6631973 · Received June 9, 2017

    Report

    Report Number
    3002769706-2017-00134
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 23, 2017
    Report Date
    August 9, 2017
    Manufacturer
    BIOMÉRIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK050043
    Removal / Correction Number
    FCA 3522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE ROOT CAUSE FOR THE ISSUE IS RELATED TO MANUFACTURING EQUIPMENT, SPECIFICALLY THE FOWLER CAPPER. THE FAILURE RESULTED IN EXCESSIVE CRIMP PRESSURE BEING APPLIED TO THE CAP WHEN THE CRIMP WAS FORMED. THIS PRESSURE LED TO EXCESS MATERIAL BENEATH THE CRIMP WHEN THE FORMING TOOL PRESSED THE CAP ONTO THE TOP OF THE BOTTLE. BASED ON THE CAPPER EQUIPMENT FUNCTIONALITY, ADJUSTMENTS MAY BE REQUIRED DURING MANUFACTURING, AS AN INCREASE OR DECREASE OF THE CAPPER MACHINE PRESSURE COULD CAUSE CUT CRIMP SEAL DEFECTS. A LIKELY CONTRIBUTING FACTOR TO THIS EVENT IS THAT ALL IMPACTED BOTTLES WERE NOT SEGREGATED AND DISCARDED AT THE TIME DISCOVERED BY MANUFACTURING PERSONNEL. AS A RESULT OF THIS COMPLAINT INVESTIGATION, CAPA 1317757 (LINE 1 CRIMP SEALS) WAS INITIATED ON 29JUN2017. ADDITIONAL ACTIONS TAKEN AS A RESULT OF THE DEFECTS BEING CAUSED BY THE MANUFACTURING ISSUE, A PRODUCT STOP SHIPMENT (PSS 3524) AND FIELD CORRECTIVE ACTION (FCA 3522) WERE ISSUED ON 12JUN2017: AS DOCUMENTED IN PSS 3524, A REQUEST WAS MADE BY THE SITE TO DISTRIBUTORS, SUBSIDIARIES, AND DIRECT CUSTOMERS TO IMMEDIATELY STOP THE SALES OF LOT 1048256 AND PUT STOCK ON HOLD. AS DOCUMENTED ON FCA 3522, THE SITE REQUESTED DISTRIBUTORS, SUBSIDIARIES, AND DIRECT CUSTOMERS TO DISTRIBUTE THE URGENT PRODUCT REMOVAL NOTICE TO ALL CUSTOMERS WHO RECEIVED THE AFFECTED LOT. CUSTOMERS WERE INSTRUCTED TO REVIEW INVENTORY OF BACT/ALERT® BPN BOTTLES FOR LOT # 1048256 AND DISCARD ALL BOTTLES FROM THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DAMAGED BOTTLE RIM ASSOCIATED WITH BACT/ALERT® BPN CULTURE BOTTLE. THE CUSTOMER REPORTED THAT A LABORATORY TRAINEE HAD BLOOD INSIDE HIS GLOVE AND INITIALLY REPORTED THAT HE DID NOT KNOW HOW HE HAD CUT HIMSELF THROUGH THE GLOVE. AN INCIDENT REPORT WAS FILED AND IT WAS REPORTED THAT THE LABORATORY TRAINEE CUT HIMSELF WHILE PRACTICING INOCULATING BOTTLES. THE CUSTOMER REPORTED THAT THERE ARE A NUMBER OF ITEMS AND PROCEDURES USED IN THE PROCESS OF INOCULATING BOTTLES AND WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CUT ON HIS FINGER. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT CRIMP ON THE BOTTLE LED TO ANY ADVERSE EVENT RELATED TO THE LABORATORY TRAINEES STATE OF HEALTH AND NO REPORT OF TREATMENT FOR THE CUT WAS PROVIDED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413342 BACT/ALERT® BPN CULTURE BOTTLE BACT/ALERT® BPN CULTURE BOTTLE MZC BIOMÉRIEUX INC. 279045 1048256

    Patients

    Seq Age Sex Outcome Treatment
    1