BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7098036 · Received December 7, 2017

    Report

    Report Number
    1710034-2017-00440
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    September 27, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7013762, MEDICAL DEVICE EXPIRATION DATE: 12/31/2019, DEVICE MANUFACTURE DATE: 01/16/2017. MEDICAL DEVICE LOT #: 6266531, MEDICAL DEVICE EXPIRATION DATE: 08/31/2019, DEVICE MANUFACTURE DATE: 09/22/2016. MEDICAL DEVICE LOT #: 7026572, MEDICAL DEVICE EXPIRATION DATE: 12/31/2019, DEVICE MANUFACTURE DATE: 01/17/2017. MEDICAL DEVICE LOT #: 7048945, MEDICAL DEVICE EXPIRATION DATE: 01/31/2020, DEVICE MANUFACTURE DATE: 02/17/2017. MEDICAL DEVICE LOT #: 7054896, MEDICAL DEVICE EXPIRATION DATE: 01/31/2020, DEVICE MANUFACTURE DATE: 02/23/2017. INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. AS REPORTED CODE: PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE EVENT DESCRIPTION: THE PACKAGES WEREN'T SEALED PROPERLY. LOT #6266531 X 1 WAS USED TOO. LOT #7048945 X 1, LOT #7054896 X1, LOT #7013762 X1 WILL BE RETURNED AS REFERENCE SAMPLES. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). THIS INCIDENT IS NEITHER; THEREFORE NO DHR REVIEW IS REQUIRED FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7026572 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM (B)(6) 2017. 7048945 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM (B)(6) 2017. 7054896 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 11 FROM (B)(6) 2017. 7013762 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 8 FROM (B)(6) 2017. 6266531 ¿ THE LOT NUMBER WAS PACKAGED ON AFA PACKAGING LINE 9 FROM (B)(6) 2016. PER REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S2 ¿ O1 AND S1 ¿ O1 LEVEL A INVESTIGATION PER (B)(4). THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: (B)(6) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED THREE UNUSED IAG 20GA UNITS FROM THE LOT NUMBER; 7026572. RECEIVED ONE UNUSED IAG 20GA UNIT FROM THE LOT NUMBER; 7048945. RECEIVED ONE UNUSED IAG 20GA UNIT FROM THE LOT NUMBER; 7045896. RECEIVED ONE UNUSED IAG 20GA UNIT FROM THE LOT NUMBER; 7013762. RECEIVED ONE UNUSED IAG 20GA UNIT FROM THE LOT NUMBER; 6266531. VISUAL/MICROSCOPIC EXAMINATION: 7073934: ONE PACKAGE WAS OPENED AT BOTH ENDS OF THE BLISTER PACK. ONE PACKAGE WAS PARTIALLY OPENED AT TOP OF THE BLISTER PACK. ONE PACKAGE WAS COMPLETELY SEALED AT BOTH ENDS OF THE BLISTER PACK. 7048945: THE PACKAGE WAS COMPLETELY SEALED AT BOTH ENDS OF THE BLISTER PACK. 7045896: THE PACKAGE WAS COMPLETELY SEALED AT BOTH ENDS OF THE BLISTER PACK. 7013762: THE PACKAGE WAS PARTIALLY OPENED AT THE BOTTOM OF THE BLISTER PACK. 6266531: THE PACKAGE WAS PARTIALLY OPENED AT THE BOTTOM OF THE BLISTER PACK. THE ANALYSIS OF TOP WEB ADHESIVE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET. IN ADDITION THE PAPER TOP WEB OF THE RETURNED UNIT WAS ANALYZED UNDER UV LIGHT. THE GLUE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED AN ADEQUATE OF TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE LOOKED AT DURING THE INVESTIGATION. TEST DESCRIPTION: VISUAL/UV LIGHT, METHOD NO.: N/A, RESULTS: SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES; THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT MET THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSIONS: THE DEFECT OF PACKAGE DAMAGE/DEFECTIVE/OTHER, AS STATED IN THE SUBJECT OF THE PIR WAS CONFIRMED WITH THE RETURNED UNIT. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH ARE: SEAL TRANSFER AND TOP WEB GLUE, MEASURED WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. DID THE EVALUATION CONFIRM THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCED WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNIT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS CONFIRMED. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THE PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY THE SEAL TRANSFER/WIDTH AND THAT PACKAGES ARE ¿WATER LEAK TESTED¿ EVERY HOUR. THESE ATTRIBUTE INSPECTIONS ARE DONE TO VERIFY THAT THE PACKAGES ARE SEALED ADEQUATELY PRIOR TO PLACING THEM WITHIN THE DISPENSER. THIS IS ISSUE IS CURRENTLY BEING INVESTIGATED BY CAPA (B)(4). CORRECTIONS AND CAPA CORRECTIVE ACTION / CAPA #: CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THE MARKINGS ON THE WASHERS. OTHER ACTIONS TAKEN (IF APPLICABLE): PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY PACKAGE INTEGRITY, INCLUDING THE VERIFICATION THAT THE PACKAGES ARE ADEQUATELY SEALED. IN ADDITION, PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING AND PACKAGING PROCESS WITH PRESCRIBED ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION(S) ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS OPENED AND UNSEALED PRIOR TO USE. NO SERIOUS INJURIES OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876970 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other