MAUDE Adverse Event Report: MERIT MEDICAL MERIT; BERN CATHETER

Model Number	510038BER
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Tip came apart from main catheter.

• Brand Name: MERIT
• Common Device Name: BERN CATHETER
• Manufacturer (Section D): MERIT MEDICAL; south jordan UT 84095
• MDR Report Key: 6485416
• Report Number: MW5069026
• Device Sequence Number: 19149453
• Product Code: DQO
• UDI-Device Identifier: 00884450011485
• UDI-Public: (01)00884450011485
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 510038BER
• Device Catalogue Number: 510038BER
• Device Lot Number: E1070459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR