BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1710034-2018-00705

    MDR report key: 7949227 · Received October 9, 2018

    Report

    Report Number
    1710034-2018-00705
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 18, 2018
    Report Date
    November 13, 2018
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 7160694: THE LOT NUMBER WAS BUILT ON AFA LINE 5 FROM (B)(6) 2017 THRU (B)(6) 2017. PACKAGED ON PACKAGING LINE 9 FROM (B)(6) 2017 THRU (B)(6) 2017. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED TWO NON-RELATED QNS WERE INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE REPORTED DEFECT. RECEIVED THREE IAG 22GA UNITS FROM LOT NUMBER 7160694. PACKAGE WAS PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNITS THAT WAS PARTIALLY OPEN AT BOTH ENDS OF THE BLISTER PACK. EVEN THOUGH THE PACKAGES WERE RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. PHOTOS SUBMITTED FOR REVIEW DISPLAYED THE SAME FINDINGS AS THE EVALUATION OF THE RETURNED UNITS. BD SUPPLIER OLIVER-TOLAS (OT) USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. (B)(4) WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETERS WERE FOUND WITH PARTIALLY OPENED PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WERE FOUND WITH PARTIALLY OPENED PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other