MAUDE Adverse Event Report: NULL PORTEX; BREATHING-CIRCUIT

Model Number C45091795D-NL

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the bag of a smiths medical breathing circuit is popping off during procedures.Four cases were reported.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: no lot number was provided; therefore, device history record review could not be performed.The returned samples were visually inspected; no damage was found.From the eight bags received, three passed the leak test; the other five failed.The leak was coming from the assembly with the bushing and the tape.The most probable root cause is production personnel did not detect the incorrect assembly of the tape.Qa alert was generated on (b)(6) 2020 to ensure that operators can detect any incorrect assembly of tape on the breathing bags.Production personnel was trained in this qa alert.Since the lot number was not reported, it?s unknown if the product was manufactured after the implementation of these changes.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12808168
• MDR Text Key: 280768763
• Report Number: 3012307300-2021-11172
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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 Model Number: C45091795D-NL
• Device Catalogue Number: C45091795D-NL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/13/2021
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1