MalfunctionBTC
PORTEX
Received Mar 24, 2022 · Event occurred Nov 1, 2021
Report 3012307300-2022-05226 · MDR key 13887262
Device
Generic name
Bag, Reservoir
Manufacturer
Smiths Medical International, Ltd.Model number
101/870/070CZCatalog number
101/870/070CZ
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED. THE CUSTOMER STATED THIS HAPPENED WITHOUT CONTACT WITH SHARP OBJECTS OR APPLIED PRESSURE. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. THE PROBLEM SOURCE IS DESIGN. DHR REVIEW WAS NOT COMPLETED AS NO LOT NUMBER WAS PROVIDED.