UNKNOWN TEMPORARY PACING ELECTRODE
Received Apr 17, 2025 · Event occurred Mar 28, 2025
Report 1018233-2025-02739 · MDR key 21854986
Device
Generic name
Temporary Pacing Electrode
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog number
UNK
Lot number
UNK
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE BALLOON FLOW-ASSIST TPE, AND THE PATIENT EXPERIENCED "CATHETER DISPLACEMENT", AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE BALLOON FLOW-ASSIST TPE, AND THE PATIENT EXPERIENCED "CATHETER DISPLACEMENT", AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.