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

Lot Number I2387753

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

While total proctocolectomy (tpc) was removed, the cuff that attaches to the tube had been dislodged at an unknown time and was free floating under the skin.An additional incision had to be made to find the cuff and remove it.

• Brand Name: ASPIRA TUNNELED PLEURAL CATHETER
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 18182508
• MDR Text Key: 328678739
• Report Number: 18182508
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/09/2023

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: Health Professional
• Device Lot Number: I2387753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: Black Or African American