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

Catalog Number 21-2733-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Coma (2417)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Potential lot number for the device: 3677354.

Event 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9101004
• MDR Text Key: 159452128
• Report Number: 3012307300-2019-05023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K870866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 21-2733-24
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other