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

Catalog Number C45101340-NLJ

Device Problem Leak/Splash (1354)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

D4: udi is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found sample presented pinholes on the breathing bag.Functional testing confirmed the issue; sample was rejected by the leak test equipment due to damage / broken on the breathing bags.The root cause of the reported issue, based on the investigation results, there is leakage due to pinholes on the raw material breathing bag provided by the supplier.Corrective actions will be addressed and implemented trough supply notification.

Event Description

It was reported that during pre-test, when inflating the bag, the customer found a crack/tear in it.No patient injury reported.

• Brand Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Type of Device: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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: 16867814
• MDR Text Key: 314547161
• Report Number: 3012307300-2023-05047
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K95452
• 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
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 4118159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1