BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6932770 · Received October 9, 2017

    Report

    Report Number
    1710034-2017-00224
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 13, 2017
    Report Date
    December 10, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED / AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY THE DESIGNATED COMPLAINT HANDLING UNIT (DCHU). EVENT DESCRIPTION: THE PACKAGES WERE NOT SEALED. 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 INVESTIGATION IS CLASSIFIED AS MDR. FINDINGS: LOT #6239771: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AUTOGUARD LINE 10 AND PACKAGED ON PKG LINE 11 STARTING ON MAR 26, 2017 THROUGH MAR 27, 2017. ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) BLISTER THICKNESS, SEAL TRANSFER WIDTH, BAD SEAL AND WATER LEAK TEST PASSED PER SPECIFICATION. LOT #7059847: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED AND PACKAGED ON AUTOGUARD LINE 11 STARTING ON MAR 3, 2017 THROUGH MAR 4, 2017. ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) BLISTER THICKNESS, SEAL TRANSFER WIDTH, BAD SEAL AND WATER LEAK TEST PASSED PER SPECIFICATION. LOT #4203595: A TOTAL OF 432,610 UNITS WERE MANUFACTURED ON AUTOGUARD LINE 9 STARTING ON SEP 10, 2014 THROUGH SEP 16, 2014 AND PACKAGED ON PKG. LINE 11 FROM SEP 16, 2014 TO OCT 10, 2017 (STOPPED AND STARTED). ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) BLISTER THICKNESS, SEAL TRANSFER WIDTH, BAD SEAL AND WATER LEAK TEST PASSED PER SPECIFICATION. LOT #4248880: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AUTOGUARD LINE 9 STARTING ON SEP 10, 2014 THROUGH SEP 16, 2014 AND PACKAGED ON PKG. LINE 11 FROM SEP 16, 2014 TO OCT 10, 2017 (STOPPED AND STARTED). ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) BLISTER THICKNESS, SEAL TRANSFER WIDTH, BAD SEAL AND WATER LEAK TEST PASSED PER SPECIFICATION. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR 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)(4) VERSION I WAS REVIEWED AND DETERMINED TO HAVE APPROPRIATE ASSESSMENT OF RISK RELATED TO THIS DEFECT. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 9 IAG BC 20GA UNITS, 4 UNITS FROM LOT NUMBER 6239771, 3 UNITS FROM LOT NUMBER 7059847, 1 UNIT FROM LOT NUMBER 4203595 AND 1 UNIT FROM LOT NUMBER 4248880 LOT 6239771: 2 UNITS WERE OPEN AT BOTH ENDS; 2 UNITS WERE OPEN AT ONE END. LOT 7059847: 3 UNITS WERE NOT OPEN (PACKAGE WAS INTACT). LOT 4203595: 1 UNIT WAS NOT OPEN (PACKAGE WAS INTACT). LOT 4248880: 1 UNIT WAS OPEN AT BOTH ENDS. NOTE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. A SAMPLE SIZE OF ONE UNIT PER LOT NUMBER WAS TAKEN AND WAS ANALYZED UNDER UV LIGHT. THE ADHESIVE 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 PAPER TOP WEB GLUE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE OBSERVATIONS. TEST DESCRIPTION: METHOD NO.: RESULTS: VISUAL/MICROSCOPIC, N/A, SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES; ALTHOUGH THE DEFECT WAS CONFIRMED, THE UNITS EVALUATED FOR THIS INCIDENT PASSED THE MANUFACTURING SPECIFICATION REQUIREMENTS. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. CONCLUSIONS: THE DEFECT OF PACKAGE DAMAGED / DEFECTIVE / OTHER AS STATED IN EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO MEET SPECIFICATION. NO ANOMALIES WERE FOUND. DID THE EVALUATION CONFIRM THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? YES; THE FAILURE THAT THE CUSTOMER EXPERIENCED WAS CONFIRMED. 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. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE COMMENT: ALTHOUGH THE PACKAGES WERE RECEIVED OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS. OTHER ACTIONS TAKEN (IF APPLICABLE): 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.

    Additional Manufacturer Narrative · 1

    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 PACKAGES OF LOT ,4248880, 4203595, AND 7059847 WERE NOT SEALED APPROPRIATELY AND PACKAGES WERE DAMAGED. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708383 20 G X 1.16" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6239771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other