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

Catalog Number CA13E0/4K1/004JP

Device Problem Gas/Air Leak (2946)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.No patient injury reported.No additional information is available for this complaint.

Manufacturer Narrative

Date of event: month and year have been provided, day is unknown.Lot number, udi section, expiration date and manufacture date are unknown, no information has been provided to date.Device is exempt.Device evaluation: one device, a breathing bag and the breathing circuit, were returned for investigation.Observation of the returned breathing circuit revealed no abnormalities such as damage related to the reported event.Next, a leak test was conducted on the breathing circuit, but no leaks were confirmed, and it was confirmed that the product conformed to the standard.When observing the breathing bag, it was confirmed that there was a pinhole in the fold of the bag.The reported event was confirmed.No lot number was provided therefor no device history report (dhr) review could be completed.The root cause may be due to manufacturing.The sample has been sent to another investigation site for further root cause analysis.

Manufacturer Narrative

Other text: h6 conclusion codes: updated.Device evaluation: one breathing bag and breathing circuit were returned to the initial investigation site for review.Observation of the returned breathing circuit revealed no abnormalities such as damage related to the reported event.Functional testing in the form of a leak test resulted in no leaks.When observing the breathing bag it was confirmed there was a pinhole in the fold of the bag, confirming the event.The device was forwarded to another site for further root cause analysis.One device was received for investigation at the second investigation site.Functional testing in the form of a leak test was performed, confirming the complaint when a leak was detected.Based on the analysis conducted in the photos provided and the sample provided, the leak was generated by a small hole that is difficult to identify with the naked eye.The condition is consistent with something that was created by a fine and sharp tip.Based on the results of this evaluation, it is most probable that the issue was created after leaving the manufacturing facility.No lot number was provided, therefor the device history report (dhr) review could not be completed.No actions taken at this time.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING, EXPANDABLE
• 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: 16668240
• MDR Text Key: 312613231
• Report Number: 3012307300-2023-03435
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA13E0/4K1/004JP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/26/2023
• 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