MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4437-24
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that a smiths medical implantable port-a-cath had a tear following placement.This required a replacement port for the patient.
Additional Manufacturer Narrative
Other, other text: one power p.A.C.Was returned for analysis.A fissure in the septum was noted upon visual inspection.Functional testing was performed by infusing water through the port using a gripper product connected to the septum; water flowed through system with no evidence of leaks.The manufacturing process was reviewed finding production personnel performs 100% visual inspection during the assembly and production personnel performs 100% leak test operation during the manufacturing process to the ports.Based on the evidence, the root cause is unknown as the complaint is not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture., corrected data: g7, previously submitted 31-oct-2018.

• Brand Name: PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7736487
• Report Number: 3012307300-2018-02930
• Device Sequence Number: 10950658
• Product Code: LJT
• UDI-Device Identifier: 00610586032663
• UDI-Public: 00610586032663
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: Health Professional
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: 21-4437-24
• Device Lot Number: 87X329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown