MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL IMPLANTABLE PORTS DELTEC GRIPPER NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2733-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Coma (2417)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Potential lot number for the device: 3677354.
Event or Problem Description
Information was received that while a smiths medical implantable port was in use, fluid built around the port a cath.Patient was admitted to the hospital for removal of the port a cath and the patient became in a comatose state.No further information has been received.

• Brand Name: SMITHS MEDICAL IMPLANTABLE PORTS DELTEC GRIPPER NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9101004
• Report Number: 3012307300-2019-05023
• Device Sequence Number: 2664750
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 21-2733-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other