MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC PROPORT PORTS; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4187-24
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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 a rupture in the base of the implantable chamber was detected.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
D1 - brand name, d2a - common device name, d2b - procode, d4 - expiration date, and d4 - primary udi number: corrected.H3 and h6.Codes: updated.Device evaluation: received one (1) used device sample.As received the catheter was observed to be torn.A portion of the catheter was found lodged onto the port of the proport.Upon removal of the catheter the port on the proport was observed to be broken.The deformation on the area appeared to be cold form damage, with an ovular pinched like shape.The complaint of ruptured base can be confirmed due to the observed damage on the proport port.The probable cause is due to unintentional bending/twisting forces applied during use.Additionally, during investigation, the catheter was observed to be torn in two.The probable cause of the tear is unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: DELTEC PROPORT PORTS
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20500221
• Report Number: 9617604-2024-00829
• Device Sequence Number: 17950882
• Product Code: LJT
• UDI-Device Identifier: 10610586012839
• UDI-Public: (01)10610586012839(17)290428(10)6013085
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 21-4187-24
• Device Lot Number: 6013085
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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