MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101324-NLJ

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: d4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank, device is exempt.D3, g1, and g2 email is: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during a pre-use check, there was a hole about two (2) to three (3) mm in the anesthesia bag.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One device sample was received without the original packaging.Per visual inspection, it was possible to detect the breathing bag was damaged.The complaint was confirmed.Other analysis, the process was reviewed to try to identify somewhere that could result in the damage presented in the part returned, nothing was found on the workstation that could cut the breathing bag during the review.The root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from the assembly process.According to what was reported by the customer, it is mentioned that the bag had a hole of about 2 to 3 mm, which indicates that the breathing bag was manipulated or subjected to some process to obtain the level of tear that the returned component presents.However, the reported initial hole issue comes from supplier.A device history record (dhr) review could not be performed as the lot number was unknown.Notification was made to the supplier for the breathing bag issue.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18241225
• MDR Text Key: 329589329
• Report Number: 3012307300-2023-10891
• 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
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101324-NLJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1