MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101340-NLJ

Device Problems Device Alarm System (1012); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Potential lot number: 3194024, 3231529, 3231530, 3232362, and 3232363.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.(b)(4).

Event Description

It was reported that a portex® disposable anesthesia breathing circuit was in use with an anesthesia machine when a leak alarm occurred.It was observed that there was a break on the upper part of the anesthesia bag.The device was in use for one minute before the issue was observed.No patient injury was reported.The event was considered resolved.

Manufacturer Narrative

One device was returned for evaluation without its original packaging.Visual inspection of the device found a tear on the bag.Functional testing involved a leak test, which the device failed.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process for a similar part number was performed (same manufacturing procedures, process controls, and inspections) and found no issues.Based on the evidence, the most probable root cause was attributed to a supplier issue; the bag was received damaged from the supplier and leak test did not properly identify the issue prior to distribution.

• Brand Name: PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6147438
• MDR Text Key: 61552759
• Report Number: 3012307300-2016-00459
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1