MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS; CATHETER MOUNTS

Catalog Number 100/594/000

Device Problem Defective Component (2292)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the connector was found broken.No patient injury was reported.

Manufacturer Narrative

The device was returned to smiths medical.Since the part received was out of the pouch, after reviewing the tests and inspections performed during the manufacturing of the part walkthrough and since part was handled prior manufacturing the root cause can't be determined whether this defect is attributable to manufacturing.No lot number provided for dhr.

• Brand Name: PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS
• Type of Device: CATHETER MOUNTS
• Manufacturer (Section G): NULL
• MDR Report Key: 13538547
• MDR Text Key: 285703025
• Report Number: 3012307300-2022-03445
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/594/000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1