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

Catalog Number CA13B0/400/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the breathing bag was observed.No adverse patient effects were reported by the customer.It was reported that no additional information is available for this event.

Manufacturer Narrative

B3: month and year have been provided, day is unknown.D4: udi section, expiration date and h4: manufacture date are not available based on the reported lot number.G5: 510k is blank, device is exempt.One device has been received for investigation.Functional testing showed the breathing circuit conformed to the standard, but the breathing bag did not conform to the standard.Review of the device history reports (dhr), relevant to the lot reported, found no discrepancies or anomalies.An issue with the molding of the bag rather than external damage was thought to be related to the reported issue.Device was forwarded to another investigation site for further root cause analysis.That secondary investigation is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Other, other text: d10, h6 evaluation codes: updated one breathing circuit and breathing bag were returned for investigation.Visual inspection occurred and found that there was no abnormality in the breathing circuit, but there were holes in the tip and fold of the breathing bag.The leak test was performed on the returned sample and confirmed a leak was present.The complaint was confirmed due to a pin hole in the breathing bag which causes air leakage.The occurrence of this failure condition could be caused by material damaged during the product handling.No action taken.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT
• 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: jim vegel
• MDR Report Key: 17034908
• MDR Text Key: 316289999
• Report Number: 3012307300-2023-05919
• 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: 06/23/2023

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: CA13B0/400/000JP
• Device Lot Number: 230313
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• 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