MAUDE Adverse Event Report: NULL ADAPTOR TUOHY-BORST; ACCESSORIES, CATHETER

Catalog Number B1220

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.A sample was received to perform an investigation.Inspection found that the returned sample was within specification.A functional leak test was performed by manually introducing water with a syringe and the sample did not exhibit any leakage.The root cause cannot be established as the reported problem could not be confirmed with the sample received.A device history record (dhr) review was performed and found no discrepancies observed during the manufacturing of this lot.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that during use of the device, there was leakage from the adaptor.Nothing passed through the reported adaptor when leakage occurred.No patient injury was reported.

• Brand Name: ADAPTOR TUOHY-BORST
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section G): NULL
• MDR Report Key: 15327580
• MDR Text Key: 304874717
• Report Number: 3012307300-2022-17010
• Device Sequence Number: 1
• Product Code: KGZ
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: B1220
• Device Lot Number: 4005811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1