BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LUER ADAPTOR

    MDR report key: 11823181 · Received May 13, 2021

    Report

    Report Number
    2243072-2021-01463
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: 20068006. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 5/26/2020. D.4. MEDICAL DEVICE LOT #: 21038124. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2/23/2021. D.4. MEDICAL DEVICE LOT #: 21038131. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2/23/2021 D.4. MEDICAL DEVICE LOT #: 20058083. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 4/28/2020. D.4. MEDICAL DEVICE LOT #: 20058079. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 4/28/2020. D.4. MEDICAL DEVICE LOT #: 20044388. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 4/22/2020. D.4. MEDICAL DEVICE LOT #: 20044166. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 4/16/2020. D.4. MEDICAL DEVICE LOT #: 20034493. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 3/19/2020. D.4. MEDICAL DEVICE LOT #: 20058090. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 4/28/2020. D.4. MEDICAL DEVICE LOT #: 21038635. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 3/8/2021. H.6. INVESTIGATION: DHR WAS PERFORMED AND NO QN¿S WERE FOUND DURING THE MANUFACTURING OF THE LOTS REPORTED IN THIS COMPLAINT. A TREND REVIEW WAS PERFORMED FOR MODEL 1013-156-004 AND NO QNS RELATED TO THIS FAILURE MODE WERE FOUND IN A 12- MONTHS PERIOD (JUNE 13TH, 2020 TO JUNE 13TH, 2020). A TREND REVIEW WAS PERFORMED FOR 1013-156-004 AND NO ADDITIONAL COMPLAINTS RELATED TO THIS FAILURE MODE WERE FOUND IN A 12- MONTHS PERIOD (JUNE 13TH, 2019 TO JUNE 13TH, 2020). IT WAS REPORTED THAT ALL THE INSPECTED SAMPLES HAD A MARK PRESENT ON THE KNIT LINE. (B)(4) PIECES FROM 9(NINE) DIFFERENT LOTS WERE RECEIVED AND REPORTED BY FAILURE MODE COMPONENT DAMAGE-COSMETIC ISSUES. VISUAL INSPECTION OF THE SAMPLES WAS CARRIED OUT TOGETHER WITH THE MOLDING QUALITY ENGINEER AND MOLDING PROCESS ENGINEER. NO OTHER ISSUE WAS OBSERVED. NEVERTHELESS, ONCE SAMPLES WERE INSPECTED, IT WAS NOTED THAT THE MARKS REPORTED BY THE CUSTOMER ARE THE RESIN FLOW ENDS. THAT IS THE REASON THAT THE INJECTION POINT IS BEHIND OF THE MARK. AFTER THIS COMPARISON , IT COULD BE CONCLUDED AND CONFIRMED BY MOLDING QUALITY ENGINEER AND MOLDING PROCESS ENGINEER, THAT THE REPORTED BY CUSTOMER AS A COSMETIC ISSUE IS NOT MORE THAN A CONDITION GENERATED BY THE RESIN FLOW IN ALL CAVITIES, IT IS NOT A CRACK, IT IS A CONDITION THAT DOES NOT AFFECT THE MALE LUER ADAPTOR FUNCTIONALITY. ROOT CAUSE DEFINITION THE CONDITION REPORTED BY CUSTOMER UNDER THIS COMPLAINT WAS CONFIRMED (BASED ON HOW THE CUSTOMER REPORTED THE ISSUE), HOWEVER, THE PIECES WERE VISUALLY INSPECTED, AND IT WAS NOTED THAT THE MARKS REPORTED BY THE CUSTOMER ARE PART OF THE INJECTION PROCESS. NO ACTIONS WERE DEFINED SINCE THE MARKS REPORTED BY THE CUSTOMER AS A COSMETIC ISSUE, WERE FOUND THAT ARE PART OF THE MOLDING PROCESS. IT IS NOT A CRACK OR DAMAGE; IT IS A CONDITION THAT DOES NOT AFFECT THE MALE LUER ADAPTOR FUNCTIONALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MALE LUER ADAPTOR WAS DAMAGED ON 4 OCCASIONS AND THERE WERE CONNECTION ISSUES ON 500 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1: MATERIAL #: 1013-156-004 . BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT ONE OF THE LUER CONNECTIONS WAS FOUND BROKEN IN THE PACKAGE. EVENT 2: MATERIAL #: 1013-156-004. BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT ONE OF THE LUER CONNECTIONS WAS FOUND BROKEN IN THE PACKAGE. EVENT 3-11: MATERIAL #: 1013-156-004 BATCH/ LOT #: 20068006, 21038124, 21038131, 20068006, UNKNOWN, 20058083, 20058079, 20044388, 20044166, 20034493. IT WAS REPORTED THAT ALL THE INSPECTED SAMPLES HAD A MARK PRESENT ON THE KNIT LINE. VERBATIM: WE PURCHASE YOUR ADAPTER MALE SLIP LUER, .156 TUBING. I WANTED TO NOTIFY YOU THAT WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS. THE COMPLAINT REPORT STATED THE FOLLOWING: THE LUER CONNECTION PROBLEM IS GETTING WORSE. NOW WE FOUND ONE BROKEN IN THE PACKAGE. ADDITIONALLY, ONE OF OUR FACILITIES DID A SAMPLING INSPECTION ON REMAINING INVENTORY OF THE LUER AND FOUND ALL INSPECTED SAMPLES HAD A MARK PRESENT ON THE KNIT LINE. ALL OF OUR INVENTORY IS CURRENTLY ON HOLD DUE TO THIS DEFECT FOUND IN THE LUER.

    Additional Manufacturer Narrative · 1

    THIS SITE IS AN OEM MANUFACTURING SITE. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MALE LUER ADAPTOR WAS DAMAGED ON 4 OCCASIONS AND THERE WERE CONNECTION ISSUES ON 500 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1: MATERIAL #: 1013-156-004, BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT ONE OF THE LUER CONNECTIONS WAS FOUND BROKEN IN THE PACKAGE. EVENT 2: MATERIAL #: 1013-156-004 , BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT ONE OF THE LUER CONNECTIONS WAS FOUND BROKEN IN THE PACKAGE. EVENT 3-11: MATERIAL #: 1013-156-004, BATCH/ LOT #: 20068006, 21038124, 21038131, 20068006, UNKNOWN, 20058083, 20058079, 20044388, 20044166, 20034493. IT WAS REPORTED THAT ALL THE INSPECTED SAMPLES HAD A MARK PRESENT ON THE KNIT LINE. VERBATIM: WE PURCHASE YOUR ADAPTER MALE SLIP LUER, .156 TUBING. I WANTED TO NOTIFY YOU THAT WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS. THE COMPLAINT REPORT STATED THE FOLLOWING: THE LUER CONNECTION PROBLEM IS GETTING WORSE. NOW WE FOUND ONE BROKEN IN THE PACKAGE. ADDITIONALLY, ONE OF OUR FACILITIES DID A SAMPLING INSPECTION ON REMAINING INVENTORY OF THE LUER AND FOUND ALL INSPECTED SAMPLES HAD A MARK PRESENT ON THE KNIT LINE. ALL OF OUR INVENTORY IS CURRENTLY ON HOLD DUE TO THIS DEFECT FOUND IN THE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713663 MALE LUER ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1