MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; BREATHING-CIRCUIT

Model Number CA13B0/4P5/000JP

Device Problem Material Fragmentation (1261)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the cushion was found torn.No patient injury.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.A sample was received for evaluation in an opened package.During visual inspection, the reported problem was verified.The cushion was deflated and a scratch on the cushion part was found.A v-shaped cut was found on the mask cushion.The scratches resembled those made with sharp blades.This issue was not associated with a pattern or a trend.Since the visual inspection of this product is not required in the manufacturing procedure, it is probable that it was difficult to detect this defect.Root cause was found to be a supplier item fault.The sample was sent to supplier for further investigation.D4 (udi), g3, g5 are unknown.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 12725652
• MDR Text Key: 279259805
• Report Number: 3012307300-2021-10490
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA13B0/4P5/000JP
• Device Catalogue Number: CA13B0/4P5/000JP
• Device Lot Number: 210819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1