MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number C45091795D-NL

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the bag was popping off during procedures.

Event Description

There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

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.A quality alert was generated on 18-mar-2020 to ensure that operators can detect any incorrect assembly of tape on the breathing bags.Production personnel was trained in this quality alert.Since the lot number was not reported, it?s unknown if the product was manufactured after the implementation of these changes.No patient involvement.(updated b5 and h6a), corrected data: d1, d3, d4b, g2, g3.

Event Description

The reported issue involved a patient during procedure.No observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCU
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12840902
• MDR Text Key: 281006297
• Report Number: 3012307300-2021-11532
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2023

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 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: 11/18/2021
• Supplement Dates Manufacturer Received: 09/07/2022; 01/10/2023
• Supplement Dates FDA Received: 10/05/2022; 01/16/2023
• 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