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

Catalog Number C37101678D-NL

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

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.(b)(4).

Event Description

It was reported that at the beginning of the procedure while performing induction, the breathing circuit disconnected between the elbow and the y piece of the mask during holding of the mask.It was reported that a leak test was performed prior to use.There were no adverse health outcomes reported.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection found that the elbow and y-connector were not disconnected.Functional testing involved a force test and found the device met with iso specifications and passed the force test.A review of the testing and inspection documents was performed and found to be adequate.A review of the manufacturing process was performed with a similar part (same process procedures, process controls, product tests, line equipment, process flow, and components) and found no disconnections between elbow and the y-connector.Based on the evidence, the root cause was unable to be confirmed as the device met manufacturing specification.

• Brand Name: PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• 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.; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6200960
• MDR Text Key: 63193524
• Report Number: 3012307300-2016-00586
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: C37101678D-NL
• Device Lot Number: 3259243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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