MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number VP1332

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

(udi) and g5 (510k) are unknown; no additional information was provided.This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Sample received consisted of one (1) product, in used conditions without its original packaging.The sample was visually inspected at a distance of 12 inches under normal lighting to received units, in order to detect any damage on the unit; it was found that the breathing bag is torn.The most probable root cause is that the production personnel did not detect and scrapped the damaged breathing bag.Action(s) taken to mitigate the reported issue(s): qalert was generated and production personnel was trained to ensure detection of any marks or damage on the breathing bags.

Event Description

It was reported that the breathing bag has sheared off at the circuit connector spot.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 15638650
• MDR Text Key: 306496491
• Report Number: 3012307300-2022-25373
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: VP1332
• Device Lot Number: 3727581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 44 KG