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

Catalog Number C49291349-NLJ

Device Problems Air Leak (1008); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

A report was received stating that the listed device was in use for 15 minutes when the ventilator alarmed.The user reportedly found a tear in corrugated tubing, which caused a leak in the system and the alarm on the ventilator.There were no adverse effects to the pt.

Manufacturer Narrative

Three unused corrugated tubes, from the same lot, were returned for product eval.During visual inspection, no cracks, holes, or defects were discovered in any of the returned products.Each tube was functionally tested.No leaks were observed; the tubes were found to operate as intended.The tubes were then tensile tested.All strength testing results passed spec.The reported product fault could not be duplicated.No evidence was found to suggest the reported event was caused by an intrinsic product fault.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundry rd; hyte, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4092980
• MDR Text Key: 4831139
• Report Number: 2183502-2014-00648
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: C49291349-NLJ
• Device Lot Number: 2539102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2014
• Distributor Facility Aware Date: 06/17/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1