MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA 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 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi section, expiration date and manufacture date are unknown, no information is available based on reported lot number.B3: month and year of event have been provided, day is unknown.G5 is blank, device is exempt.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 the pre-use check, leakage of air from the breathing bag was observed.No patient injury.

Manufacturer Narrative

D10: date available for evaluation, h6: evaluation codes: updated device evaluation: one device and four photos were received for investigation.The complaint was confirmed, photos showed a hole in the breathing bag and visual inspection showed a tear at the tip of the bag.Twenty samples were taken and tested to see if the defect could be duplicated in the manufacturing facility.It was concluded that failure reported could not be reproduced in the manufacturing process according to the analysis method.Based on the analysis performed on the unit returned by the customer the root cause for the failure, leaking, was caused by the tear on the breathing bag.After reviewing the mitigations that are performed during the manufacturing process to detect leaks, the root cause of the damaged is the part became damaged after it left manufacturing facilities.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken at this time.

• Brand Name: PORTEX ANESTHESIA 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: 16670043
• MDR Text Key: 312760999
• Report Number: 3012307300-2023-03450
• 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: 06/01/2023

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: 230116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1