MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE RESOLVE® LOCKING DRAINAGE.; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number	RLC-8-038MB/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that the outside hub of the resolve locking drainage catheter broke/detached after placement.The catheters were placed for ascites and nephrostomy fluid drainage.A new drainage catheter was placed for this patient.The device is not expected to return for engineering evaluation.All devices have been discarded at the account.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.The device is not expected to return for engineering evaluation.A good faith effort of 3 or more attempts to collect additional event and lot# information from this account has been completed in a timely manner.Additional information regarding this event has not been provided to merit medical.A supplemental report will be submitted if additional info is received by the manufacturer.

• Brand Name: RESOLVE® LOCKING DRAINAGE.
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21994357
• Report Number: 3011642792-2025-00072
• Device Sequence Number: 4488045
• Product Code: DXN
• UDI-Device Identifier: 00884450580714
• UDI-Public: 884450580714
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RLC-8-038MB/C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown