MEDLINE
Received Jul 28, 2026 · Event occurred Jul 17, 2025
Report 1417592-2026-11450 · MDR key 50060758
Device
Generic name
Cholangiogram Wmh
Manufacturer
Medline Industries, LpCatalog number
DYNJ62558A
Lot number
24CBO755
Product problems
- Material Twisted/Bent
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the 4.5fr cholangiogram cath is bent and unable to be used.
Additional Manufacturer Narrative
It was reported that the cholangiogram Cath is bent and unable to be used.There were no reports of death, serious injury, medical intervention, or follow up care. It has been determined that the reported event could cause or contribute to serious injury if it were to occur again. In an abundance of caution, this is a reportable event. If additional information becomes available this report will be reopened and reevaluated. This Medical Device Report (MDR) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 CFR Part 803. The information included in this MDR reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.