DEK BL MF 0 TC-43 2N 48
Received Mar 10, 2023 · Event occurred Jan 23, 2023
Report 3004365956-2023-00016 · MDR key 16522172
Device
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTED ISSUE: WHILE USING THE SUTURES PLACEMENT DEVICE, THAT IT WAS IMPOSSIBLE TO PROPERLY RECOVER THE DART. THE RESCUE WIRE WAS USED TO RETRIEVE IT. THE CONSEQUENCE FOR THE PATIENT IS AN INCREASE IN THE INTERVENTION TIME BY A FEW MINUTES. THIS IS AN ISOLATED INCIDENT. NO REPORTED INJURY.
Additional Manufacturer Narrative
QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER AND PRODUCT CODE WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT CODE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. IN CONCLUSION, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.