MAUDE Adverse Event Report: SMITHS MEDICAL CATH PORT A 21 4083; PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 21-4083-24

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2016

Event Type  Injury  

Event Description

Porta cath for chemo was placed (b)(6) 2016.Surgeon stated that the patient presented to the surgery clinic on (b)(6) 2017 to have the porta cath removed.Upon removal he noted that the catheter was not attached to the port.He noted a fracture line.The patient was admitted to hospital as a direct admission w/dx of retained broken catheter.On (b)(6) 2017 ir status post successful fluoroscopically guided snaring of a broken catheter piece from the superior vena cava which was removed in its entirety.The patient was observed overnight and discharged home stable.

• Brand Name: CATH PORT A 21 4083
• Type of Device: PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL; dublin OH 43017
• MDR Report Key: 7518205
• MDR Text Key: 108611289
• Report Number: MW5077245
• Device Sequence Number: 0
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2018
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 2526781
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 105