14" EXTENSION SET
Received Sep 18, 2014 · Event occurred Jul 24, 2014
Report 2245270-2014-00074 · MDR key 4189990
Device
Product problems
- Detachment Of Device Component
- Fluid/Blood Leak
Patient
58 YR
- No Consequences Or Impact To Patient
- Missed Dose
Narrative
Description of Event or Problem
TUBING SEPARATED FROM MALE LUER CONNECTOR WITH RESULT THAT INFUSION LEAKED OUT ONTO BEDDING. PATIENT'S FENTANYL INFUSION WAS INTERRUPTED FOR APPROXIMATELY 6 HOURS WITH RESULT IN LOSS OF PAIN CONTROL.
Additional Manufacturer Narrative
THREE PIECES OF THE MALFUNCTIONING LOT WAS RETURNED FOR TESTING. ONE PIECE WAS A MALFUNCTIONING SAMPLE TWO OTHER WERE UNUSED DEVICES. THE UNUSED DEVICES WERE PULL TESTED WITH AN AUTOMATIC TESTER, AND ALL RESULTS WERE WITHIN SPECIFICATION. A REVIEW OF THE FAILED DEVICE INDICATED THAT THE ROOT CAUSE OF THIS NONCONFORMITY WAS DUE TO HUMAN ERROR IN THE APPLICATION OF THE SOLVENT BONDING SOLUTION. THE CORRECTIVE ACTION FOR THIS MALFUNCTION WILL BE AWARENESS TRAINING FOR ALL OPERATORS INVOLVED IN THE ASSEMBLY PROCESS. ALSO, THE MANUFACTURING STAFF HAS BEEN INFORMED TO BE VIGILANT TO AVOID THIS TYPE DISCREPANCY IN THE FUTURE.