BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7342214 · Received March 15, 2018

    Report

    Report Number
    1710034-2018-00122
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 7, 2018
    Report Date
    April 17, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 7151567. THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 9 FROM JUNE 11, 2017 THRU JUNE 13, 2017. THE REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. THE REVIEW DISCLOSED DURING HAND PACKING; A WRINKLED SEALED WAS OBSERVED IN POCKET 10 FOR WHICH (B)(4) WAS INITIATED. NO FURTHER REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT WERE DISCLOSED THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING: BD RECEIVED TWO UNUSED IAG 24 GA UNITS FROM THE LOT NUMBER 7151567. ONE PACKAGE WAS PARTIALLY OPENED. ONE PACKAGE HAD A COMPLETE SEAL. APPROXIMATELY 2 INCHES FROM THE TOP OF THE BLISTER PACK THE BOTTOM WEB HAD AN INCOMPLETE PERFORATION CUT. THERE WAS A CLEAN SEPARATION ON THE TOP WEB AT THE PERFORATION CUT (SCORE LINE) BETWEEN CAVITIES 9 AND 10. PACKAGE SEAL ON CAVITY 9 WAS PARTIALLY OPEN. THE OPENING BEGAN AT THE INCOMPLETE PERFORATION CUT ON THE FILM (BOTTOM WEB). THE FILM (BOTTOM WEB) HAD STARTED TO SEPARATE FROM ITSELF. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED UNITS PROVIDED FOR EVALUATION FOR THIS INCIDENT DISPLAYED A PARTIAL OPENED PACKAGE ALONG THE SCORE LINE. THE DEFECT PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE; AS STATED AS THE REPORTED CODE WAS CONFIRMED, WITH THE RETURNED UNITS. THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNITS. THE PACKAGING ENGINEER WAS NOT ABLE TO DETERMINE HOW THE SMALL AREA OF THE FILM (BOTTOM WEB) WAS MISSED. THE REST OF THE PACKAGE HAD A CLEAN PERFORATION CUT ALONG THE SCORE LINE. ROOT CAUSE IS DETERMINED TO BE PART OF THE PACKAGING PROCESS. THE SQUEEZING KNIVES ARE PRESSED AGAINST THE SQUEEZING KNIFE ROLLER BY COMPRESSED AIR CYLINDERS. AT THE POINT WHERE THE SQUEEZING KNIVES TOUCH THE SQUEEZING KNIFE ROLLER, THE PACKAGES ARE PERFORATED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # DOES NOT EXIST FOR THE REPORTED CAT #. THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 7151567. MEDICAL DEVICE EXPIRATION DATE: 05/31/2020. DEVICE MANUFACTURE DATE: 05/31/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE B BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ¿WHEN THE CUSTOMER TRIED TO TEAR THE PERFORATION, THE PACKAGE WAS FOUND TO BE UNSEALED, THEREFORE STERILITY COMPROMISED.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183490 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7151567 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other