MAUDE Adverse Event Report: C. R. BARD, INC. BARD PORT IMPLANTED PORT WITH GROSHONG CATHETER; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603590

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 06/10/2019

Event Type  Injury  

Event Description

Implanted lifeport device was explanted with approx 3 cm of catheter portion intact.Remaining portion of catheter was not retrievable.X-rays used as comparison to one another.Fda safety report id# (b)(4).

• Brand Name: BARD PORT IMPLANTED PORT WITH GROSHONG CATHETER
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C. R. BARD, INC. ; sale lake city UT 84116
• MDR Report Key: 8879437
• MDR Text Key: 154012461
• Report Number: MW5088921
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 109