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

Catalog Number 670001

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/24/2018

Event Type  malfunction  

Event Description

It was reported when the customer attempted to perform air ventilation at a pre-use check on the product, the doctor noticed the bag was torn.During the air leak check, the product worked normally.It is not certain why the product passed the air leak check in spite that the bag was torn.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The sample was received in used conditions, without its original packaging.The sample was visually inspected at a distance of 12" under normal lighting to received units, in order to detect any damage on the unit.The breathing bag is torn.Production personnel did not detect and scraped the damaged breathing bag.Actions taken to mitigate the issue: production personnel was notified by the quality engineer on the failure mode reported by the customer.Udi is unknown.No product information has been provided to date.

• Brand Name: PORTEX GENERAL ANESTHESIA BAGS
• 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: 15656243
• MDR Text Key: 307064415
• Report Number: 3012307300-2022-25892
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172823
• 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: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 670001
• Device Lot Number: 3566654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1