MalfunctionBTC

WALKMED®

Received Jan 10, 2024 · Event occurred Jul 31, 2023

Report 18484510 · MDR key 18484510

Device

Generic name

Bag, Reservoir

Manufacturer

Walkmed, Llc

Model number

204822

Catalog number

IPR-250

Patient

21900 DA · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FROM DETAILS IN THIS EVENT REPORT, THE SLIT IN TUBING WAS LIKELY A PUNCTURE, NOT DEFECTED PRODUCT. UNSURE OF EXACT PRODUCT USED, BUT THIS IS THE PRODUCT ON HAND INFORMATION: BAG = REF: 21-7059-24 LOT 4372852. SET = REF: 204822 LOT 20322508.