MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO ASPIRA DRAINAGE CATHETER.; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 4992209/A

Device Problem Fracture (1260)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.

Event Description

The customer reports that when they hook up the adapters in the kit, the fluid would not drain.Physician used the repair kit to fix the drain issue.No additional patient consequences to report.

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 the device be returned later, the investigation will be re-opened.

• Brand Name: ASPIRA DRAINAGE CATHETER.
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16587527
• MDR Text Key: 311973265
• Report Number: 3011642792-2023-00021
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 00884450394908
• UDI-Public: 884450394908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4992209/A
• Device Lot Number: I2546597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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