MAUDE Adverse Event Report: SMITHS MEDICAL INTL LTD PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING

Catalog Number C37291334-NLJ

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received that alleges the device was found leaking immediately upon use.The report stated that a hole was found in the anesthesia breathing bag.There were no adverse effects to pt reported.

Manufacturer Narrative

Mfr completed the entire form.Device eval: one used anesthesia breathing bag was returned for eval.Visual inspection of the returned sample observed several tears in the bag material, as well as a weakening of the material near the bag's bushing.The tears and weakening of the material were found to be consistent with the device having been exposed to excessive light, heat, and/or humidity during storage.A review of the device history record revealed no defects or discrepancies related to the reported issue.Additionally, mfg conducts 100% visual inspection of these device during assembly and had the device been torn or worn at that time, it would have been detected and scrapped.There was no evidence found to suggest the event was caused by an intrinsic defect in the product.(b)(4).

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): SMITHS MEDICAL INTL LTD; hythe, kent
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3958100
• MDR Text Key: 18867421
• Report Number: 2183502-2014-00372
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Catalogue Number: C37291334-NLJ
• Device Lot Number: 1808632
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2014
• Date Device Manufactured: 05/01/2010
• 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