MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; EXPANDABLE CIRCUITS ADULT

Catalog Number CA17K0/000/000JP

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that during pre-use check, a pinhole was found in the product.No patient injury was reported.No other information is available for this complaint.

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Three (3) pictures were attached, during the analysis conducted it could be observed a top view of the bag and then a focus on a section where a damaged can be confirmed.Visual inspection: sample was received torn.When observing the breathing bag, it was confirmed that there was tear near on the crease of the bag.As part of the investigation, 20 samples were taken to see there is any condition could cause torn breathing bags.Sharp edges on binder?s workstation: the test consisted to evaluate if the condition of the binders of the process can be damage / broke the breathing bags.Packaging tested: the test evaluated if the unit can be damage due stuck.Conclusion: it is concluded that failure reported could not be reproduced in the manufacturing process according to the analysis mentioned above.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.Therefore the damage (broken) was after the product left the manufacturing facilities.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: EXPANDABLE CIRCUITS ADULT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14490055
• MDR Text Key: 292592380
• Report Number: 3012307300-2022-09537
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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: CA17K0/000/000JP
• 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: 04/25/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 11/18/2022
• 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