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

Catalog Number C48291348-NLJ

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.

Event Description

User facility reported that the listed anesthesia breathing circuit (abc) was in use with a patient for 35 minutes when it began leaking from a tear observed in its material.The reporter indicated that no adverse health outcomes resulted from event.

Manufacturer Narrative

One used product was returned and examined.Upon visual inspection, several cuts were noticed on the tubing.The cuts did not present signs of stretching and appeared to be consistent with the tubing having come into contact with a sharp object.Furthermore, the cut sections did not properly align with a segment of the tubing.Additional, damage was noted on a separate section of the tubing.The damage observed was consistent with the tubing having been smashed.Manufacturing performs a 100% leak test prior to product release; had the cuts been present at that time, the leaks would have been detected and the device would have been scrapped.No evidence was found to suggest the reported event was caused by an intrinsic product fault.

• Brand Name: PORTEX ANESTHESIA BREATHING SYSTEMS, CORRUGATED CIRCUITS
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• 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: 5572061
• MDR Text Key: 42494828
• Report Number: 2183502-2016-00769
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

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: No Information
• Device Catalogue Number: C48291348-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1