14" EXTENSION SET
Received Sep 18, 2014 · Event occurred Aug 14, 2014
Report 2245270-2014-00073 · MDR key 4178555
Device
Product problems
- Detachment Of Device Component
- Fluid/Blood Leak
Patient
30 YR
- No Consequences Or Impact To Patient
- Missed Dose
Narrative
Description of Event or Problem
PATIENT NOTICED LEAKAGE OF DRUG INFUSION AND FOUND THAT TUBING HAD SEPARATED FROM MALE LUER CONNECTOR. THE PATIENT EXPERIENCED NO ADVERSE OUTCOME OTHER THAN LOSS OF FLUID FOR ONE DOSE.
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.