Q2 T-EXTENSION SET

Additional Manufacturer Narrative

THE ALLEGED INCIDENT OCCURRED OUTSIDE THE US. THIS MEDWATCH IS BEING SUBMITTED BECAUSE QUEST MEDICAL DISTRIBUTES A SIMILAR DEVICE IN THE US. THE COMPLAINT SAMPLE WILL BE EVALUATED AND A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED DURING USE OF THE IV ADMINISTRATION EXTENSION SET. THE REPORT STATES THAT THE IV TUBING PULLED APART WHICH RESULTED IN A PATIENT NOT RECEIVING INFUSIONS AND BLEEDING FROM CENTRAL LINE INSERTION SITE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE ALLEGED MALFUNCTION DID NOT RESULT IN PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE WAS INSPECTED AND THE TUBING WAS CONFIRMED TO HAVE DETACHED. VISUAL INSPECTION SHOWED EVIDENCE OF SOLVENT IN THE FORM OF RING ON THE TUBING, CONFIRMING THE PRESENCE OF SOLVENT BONDING. PULL FORCE TESTING COULD NOT BE CONDUCTED ON THE COMPLAINT SAMPLE BECAUSE OF THE DETACHED TUBING. INVENTORY ON THE LOT ASSOCIATED WITH THIS COMPLAINT WAS DEPLETED AT THE TIME OF THE INVESTIGATION. 5 SAMPLES OF THE PRODUCT FROM ANOTHER LOT MANUFACTURED WITH THE SAME PROCESSES AND CONDITIONS AS THE COMPLAINT SAMPLE WERE PULL TESTED TO DETERMINE TUBING BOND STRENGTH. THE SAMPLES TESTED MET THE MINIMUM BOND STRENGTH SPECIFICATION OF 8 IBS. THE AVERAGE BOND STRENGTH OF THE TESTED SAMPLES WAS 14.21 IBS. A 24 MONTHS COMPLAINT HISTORY REVIEW WAS CONDUCTED ON THE PART NUMBER ASSOCIATED WITH THE REPORTED COMPLAINT AND NO SIMILAR COMPLAINT WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPLAINT LOT WAS ALSO CONDUCTED AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION IS NOT MANUFACTURING RELATED AND IS UNKNOWN. QUEST WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THE REPORTED COMPLAINT CONDITION.