MAUDE Adverse Event Report: NULL MEDEX TUBING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL

Catalog Number B1548R

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Event Description

It was reported that the issue has been discovered before the procedure has been started and the female connector was completely detached from the red stripe pressure tubing.

Manufacturer Narrative

One photo was used for investigation.Upon visual inspection, it was found that the complained issue could be duplicated.Without the actual part in hand the root cause can not be fully determined.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: MEDEX TUBING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL
• Manufacturer (Section G): NULL
• MDR Report Key: 14518315
• MDR Text Key: 292822028
• Report Number: 3012307300-2022-09786
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

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: Other
• Device Catalogue Number: B1548R
• Device Lot Number: 3980604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1