MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number	21-4083-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that after port insertion, an attempt was made to aspirate the port chamber, which was unsuccessful.Re-exposure of the port chamber confirmed that the port chamber was not functional, presumably the chamber contents had coagulated.The port chamber was then replaced.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One (1) port sample was received in used condition, inside a plastic bag which is not its original packaging (no catheter returned).It was observed that the port shows signs of use since the septum has punctures as needle has been inserted, also the port housing shows damage, no damage or other discrepancies are observed on the port-catheter connection section.Water was infused through the septum port using a syringe to detect any occlusion expecting that the water will pass through the outlet tube as intended.As result liquid passed through the device, the complaint could not be confirmed/duplicated.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19370480
• Report Number: 3012307300-2024-04033
• Device Sequence Number: 12667225
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: (01)10610586023613(17)280108(10)4392369
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 4392369
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown