MAUDE Adverse Event Report: C.R. BARD, INC. POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1859600

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2023

Event Type  Injury  

Event Description

Powerport removal by surgeon.Only a portion of the port came out.A remaining remnant of the catheter was severed internally and left in the patient.The patient then had to be scheduled for surgery for a foreign body removal.

• Brand Name: POWERPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 16398557
• MDR Text Key: 309880252
• Report Number: MW5115011
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1859600
• Device Catalogue Number: 1859600
• Device Lot Number: W0732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White