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

Catalog Number CA13B0/4K2/000JP

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: udi section, expiration date, and h4: manufacture date are not available based on the reported lot and item numbers.G5: 510k is blank, device is exempt device evaluation: one device was returned for investigation.Visual inspection noted the original package, device and components were returned.A pinhole (or tear) was found in the breathing bag.No other anomaly was observed.It was determined that the leakage occurred before the component had been supplied to that manufacturing site.To further investigate the cause of the observed condition, the device was forwarded to another investigation site for additional analysis.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.A supplemental report will be provided when further information becomes available.

Event Description

It was reported that when checking before use, a pinhole was found in the anesthesia bag.No adverse effects reported.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One device sample was received without the original packaging.Five (5) photos were included for evaluation; photos show a pin hole in the breathing bag.Per visual inspection, it was possible to detect a pin hole in the breathing bag.The complaint was confirmed.Other analysis, the process was reviewed to try to identify somewhere that could result in the damage presented in the part returned, nothing was found on the workstation that could cut the breathing bag during the review.Based on the analysis conducted in the sample provided, a root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process and is attributed to the component supplier.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective action was taken as the damage could not have been caused within the manufacturing facilities, according to the analysis performed during the investigation.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, EXPANDABLE
• 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: 18231998
• MDR Text Key: 329287911
• Report Number: 3012307300-2023-10825
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA13B0/4K2/000JP
• Device Lot Number: 230914
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• 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