BREATHING PORTEX GENERAL ANESTHESIA BAGS
Received Sep 16, 2022 · Event occurred Jun 1, 2020
Report 3012307300-2022-19426 · MDR key 15437197
Device
Generic name
Bag, Reservoir
Lot number
3458161
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CATALOG NUMBER IS UNKNOWN. UDI INFORMATION IS UNKNOWN. OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. MANUFACTURING SITE ADDRESS IS UNKNOWN. PREMARKET (510K) NUMBER IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A REVIEW OF THE MANUFACTURING PROCESS FOR WAS CONDUCTED BY QUALITY ENGINEER IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT. NO DISCREPANCIES WERE FOUND. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE SAMPLE TAPE IS NOT CORRECTLY PLACED ON THE BUSHING AND BREATHING BAG. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE OPERATOR DEPENDENT METHODOLOGY WHERE PROCEDURE WAS NOT FOLLOWED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE ADHESIVE OF THE PRODUCT DID NOT WORK AS INTENDED AND THE CONNECTOR DETACHED EASILY FROM THE ANESTHESIA BAG. NO PATIENT INJURY WAS REPORTED.