MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX DISPOSABLE SINGLE-LIMB ANESTHESIA BREATHING CIRCUITS; CIRCUIT, BREATHING

Catalog Number C1032J

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that listed device was in use during an anesthesia procedure.The oxygen value would not rise.Clinician noted the inner corrugated tube of the device was disconnected.No adverse health outcome resulted from this event.

Manufacturer Narrative

One used corrugated tubing breathing circuit was returned for product inspection.Visual inspection found the internal tubing disconnected from its connector piece.Production process was reviewed for appropriate product handling and performance verifications (leak testing) were confirmed to be operating as intended.No findings were detected at smiths medical that would cause or contribute to the internal tubing becoming disconnected from its connector piece.As the breathing circuit is a supplied item, the product supplier was notified of this issue.In addition, an added visual aid was developed to assist operators at smiths medical to properly identify this type of product problem.

• Brand Name: PORTEX DISPOSABLE SINGLE-LIMB ANESTHESIA BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5260993
• MDR Text Key: 32764182
• Report Number: 2183502-2015-00925
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: C1032J
• Device Lot Number: 3035000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2015
• 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