MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD DABC DISPOSABLE ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101314J

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

User facility reported that during use, the connector disconnected.No adverse events were reported.Additional information was requested.

Manufacturer Narrative

The reported expand, dabc, adult, str conn 85-220cm standard elbow 20 was returned for investigation.The returned device was received without its original packaging in a (b)(4) bag.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and on it was observed that one of the two 22mm connector (bushing) is missing from the tube.The probable root cause is that the 22mm connector wasn't assembled to the product and it wasn't detected on the leak test due to the fact that the test at that moment could be performed without the connector.The complaint is confirmed.

• Brand Name: DABC DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st paul 55112 ; 7633833052
• MDR Report Key: 5756277
• MDR Text Key: 48400489
• Report Number: 2183502-2016-01271
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

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: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: C45101314J
• Device Lot Number: 3136840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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