MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC LOW PROFILE PROPORT TRAY; PORT & 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	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 when the specialist was assembling the implantable device, a rupture in the base of the implantable chamber was detected.This occurred during the pretest.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4 - expiration date, and d4 - primary udi number: corrected.D9: date returned to mfg.: 10/28/2024.H3 and h6.Codes: updated.Device evaluation: received one (1) used device sample.As received 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.The probable cause is due to intentional external bending/twisting forces applied during use.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: DELTEC LOW PROFILE PROPORT TRAY
• Common Device Name: PORT & 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20640585
• Report Number: 9617604-2024-00854
• Device Sequence Number: 7489071
• Product Code: LJT
• UDI-Device Identifier: 10610586012839
• UDI-Public: (01)10610586012839(17)290610(10)6026683
• 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,User Facility
• 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: 6026683
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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