MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING RESOLVE LOCKING DRAINAGE CATHETER; IRRIGATION CATHETER

Catalog Number	RLC-12-038MB/B
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should photos or videos of the defect be provided, the complaint will be reopened and updated.
Event or Problem Description
The account alleges that when flushing a pleural drainage catheter that was placed within a patient at a later date, a tiny hole was noticed near the hub of the catheter.No medical or surgical intervention was required.The procedure was successfully completed, and the device use was discontinued.A new device was not placed within the patient.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 12407356
• Report Number: 3010665433-2021-00070
• Device Sequence Number: 17466093
• Product Code: GBX
• UDI-Device Identifier: 00884450009857
• UDI-Public: 884450009857
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 04/27/2024
• Device Catalogue Number: RLC-12-038MB/B
• Device Lot Number: E2112230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1