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

Catalog Number CA17K0/000/004JP

Device Problem Material Puncture/Hole (1504)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported that during pre-testing there was a small hole in the anesthesia bag discovered.No adverse effects have been reported.

Manufacturer Narrative

Other text: d4: expiration date and h4: manufacture date are unknown, no information is available based on the reported lot number.G5: 510k is blank, device is exempt.Device evaluation: one device was returned for investigation.Visual inspection of the returned components found a pinhole in the breathing bag and a tear in the breathing circuit.During functional testing, the pinhole in the breathing bag was confirmed.No other anomaly was observed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.To further investigate the cause of the observed condition, the device was forwarded to another investigation site for additional analysis.A supplemental report will be provided when further information becomes available.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Secondary component investigation: one device sample was received in used condition without original package.Four photos were included for evaluation; photos showed a pin hole in the complaint sample.Per visual inspection, the complaint was confirmed, a pin hole was found in the breathing bag.Based on the analysis conducted, the root cause could be due to nonconforming material from the supplier.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed they have been executed accordingly, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation with the supplier.

• 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: 17775735
• MDR Text Key: 323757259
• Report Number: 3012307300-2023-09040
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA17K0/000/004JP
• Device Lot Number: 230508
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• 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