MAUDE Adverse Event Report: PORT-A-CATH ; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Break (1069); Disconnection (1171); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Received notice from home infusion provider (b)(6) that pt has reported to them that the 2nd port-a-cath device and that the port and infusion line had separated and one item migrated and had to be surgically removed.Break - disconnection not noted on 1st trip to er to have port evaluated.Pt to now have a 3rd port-a-cath device placed over a 6 month period.Sa/e reported due to character limitations complete dosing info; infuse gamunex 10 gm (100ml) intravenously at 30 ml/hr x 15 mins, 45 ml/hr x 15 mins; 60 ml/hr x 15 mins and 80 ml/hr until done over 1.5-2 hours every 2 weeks via piv and pump.Do you have a picture of the product? no.

• Brand Name: PORT-A-CATH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 9295715
• MDR Text Key: 166334543
• Report Number: MW5090986
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization