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

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Unit returned was received inside of a plastic bag which is not the original package.Sample were received damage (broken), to determine the confirmation of the complaint, see the complete investigation and the root cause section.Other analysis: as part of the investigation, 20 samples were taken to see there is any condition could cause damage (broken): 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 teste: the test consisted to evaluate in this process 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.

Event Description

It was reported that during the pre-use check, the breathing bag was found damaged.No patient injury was reported.

• Brand Name: PORTEX DISPOSABLE 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13451410
• MDR Text Key: 287285355
• Report Number: 3012307300-2022-02543
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• 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