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

Catalog Number CA25B0/400/000JP

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

D4: expiration date and h4: manufacture date are unknown, no information is available based on reported lot number.B3: date of event and d4: udi number is unknown, no information has been provided to date.G5: 510k 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.

Manufacturer Narrative

Three (3) photos were provided.Photo one shows an anesthesia breathing circuit of part number ca25b0/400/000 next to its original packaging, the circuit corrugated tube and bag are observed in the photo; no damage or dysfunctional conditions are observed.Photo two shows the gas sampling elbow where it's observed that the luer connector port, and cap, is broken and missing.Photo three shows a close-up of where the luer connector port was broken from.One (1) unit of part number c37101308j was received without its original packaging.During the visual inspection, the gas sampling elbow was received broken with the luer connector and cap missing.The corrugated tube circuit does not present damage or other dysfunctional conditions that could cause the reported failure.During a functional test, no leakage was detected in the corrugated tubing.A review of the manufacturing device history records found no non conformances related to the reported issue.Based on the analysis performed on the unit returned by the customer the root cause for the failure, leaking, was caused by the broken gas sampling elbow connector.After reviewing the mitigations that are performed during the manufacturing process to detect leaks, the root cause of the broken elbow is the part became damaged after it left shm facilities.

• 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: 16678366
• MDR Text Key: 312793532
• Report Number: 3012307300-2023-03524
• 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: 06/02/2023

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: CA25B0/400/000JP
• Device Lot Number: 230106
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/01/2023
• 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