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

Catalog Number CA1300/4K2/000JP

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that leakage of air from the breathing bag was observed.No patient injury was reported.

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.D4: expiration date, udi number and h4: manufacture date are unknown, no information is available based on reported lot number.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 required.

Manufacturer Narrative

Other, other text: d10: device available for evaluation and h6 conclusion codes: updated device evaluation: a review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.One device was returned for investigation, visual inspection noted the breathing bag had a hole in the center.The complaint was confirmed, the pinhole in the bag caused the leak.Judging from the shape, the hole at the tip is considered not to be a damaged hole but to be caused by molding.Therefore, it is considered that pinhole occurred before being supplied to smith's manufacturing facilities.The sample will be sent to another investigation site for more detailed investigation and further root cause analysis.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.Two samples were received in use condition without original packaging.Visual inspection showed perforations on both devices.A leak test was performed in which both devices failed.The reported complaint is confirmed.Based on the analysis conducted, the leak was generated by a small hole in both bags, the most probable cause of this condition is improper handling of the product outside of the manufacturing facility.A device history record (dhr) review was not conducted due to the improper handling of the product outside of the manufacturing facility.No corrective actions are being 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: 16777248
• MDR Text Key: 313725167
• Report Number: 3012307300-2023-04337
• 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,Followup
• Report Date: 05/12/2023

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: CA1300/4K2/000JP
• Device Lot Number: 230215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 05/03/2023
• Supplement Dates FDA Received: 05/03/2023; 05/12/2023
• 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