RESOLVE® LOCKING DRAINAGE.CATHETER.10F.PIGTAIL.MARKER BAND.0.038" (0.97 MM)
Received Aug 12, 2025 · Event occurred Jul 23, 2025
Report 1721504-2025-00240 · MDR key 22787641
Device
Generic name
Catheter, Irrigation
Manufacturer
Merit Medical Systems Inc.Model number
00884450580615Catalog number
RLC-10-038MB/C
Lot number
I3076036
Product problems
- Crack
- Fracture
- Crack
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND CORRECTIVE ACTIONS ARE TAKEN AS WARRANTED. TREND DATA WILL BE USED TO MONITOR COMPLAINTS AND THE PERFORMANCE OF PRODUCTION PROCESSES AND QUICKLY ADDRESS ANY DEVIATIONS FROM ESTABLISHED STANDARDS.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
CUSTOMER REPORTS WHILE EXCHANGING A MULTIPURPOSE DRAIN THAT HAD A CRACK IN THE CATHETER, THE CATHETER FELL APART AT THE RADIOPAQUE MARKER LEAVING PART OF THE CATHETER IN THE PATIENT. THEY WERE ABLE TO EVENTUALLY GET THE REST OF THE CATHETER OUT BUT ON INSPECTION IT APPEARS IT WAS ALSO COMING APART ON THE DISTAL SIDE OF THE MARKER AS WELL. NO ADDITIONAL PATIENT DETAILS WERE PROVIDED AND NO INJURY WAS REPORTED.