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

Catalog Number	21-4477-24
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9101003
• Report Number: 3012307300-2019-05026
• Device Sequence Number: 2664475
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: 21-4477-24
• Device Lot Number: 3837449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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: Required Intervention