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

Catalog Number 21-4477-24

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  Injury  

Event Description

Information was received that while a smiths medical implantable port was in use, it had to be replaced with another.It was reported that the catheter would not fit into the port.No patient injury occurred as a result.

Manufacturer Narrative

One deltec power port was returned for analysis in used condition.Upon visual examination the catheter was noted to not be completely inserted.The catheter was removed from the port.The port was tested with a new catheter; components were found to be correct.Relevant documents were reviewed and deemed adequate.Ports line clearance record, training records, and tube coating operation were all reviewed; no discrepancies were found.The tube coating operation was further reviewed by auditing 32 units; no discrepancies were observed.Based on the evidence, the complaint was confirmed.The most probable root cause was manufacturing as the tube was not properly covered with silicone.

• 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
• MDR Report Key: 9101003
• MDR Text Key: 241261152
• Report Number: 3012307300-2019-05026
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (y/n): N
• PMA/PMN Number: K870866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 21-4477-24
• Device Lot Number: 3837449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention