DEK BL MF 0 TC-43/HR 26 2N
Received Jul 1, 2019 · Event occurred Jun 6, 2019
Report 3004365956-2019-00177 · MDR key 8750374
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SACROSPINOUS FIXATION A CAPIO SLIM NEEDLE TIP HAS BROKEN OFF.
Additional Manufacturer Narrative
QN#(B)(4). DEVICE HISTORY RECORD OF BATCH NUMBERS 74H1800970, 74H1800969 & 74D1801340 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. A NONCONFORMANCE WAS ISSUED FOR ANOTHER CONDITION THAT IS NOT RELATED TO THE FAILURE MODE REPORTED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT CODE TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE.
Additional Manufacturer Narrative
(B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER NOR PRODUCT CODE WAS 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. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SACROSPINOUS FIXATION A CAPIO SLIM NEEDLE TIP HAS BROKEN OFF.