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

Catalog Number	21-4425-24
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 stated that the catheter was connected to the chamber with the front part (tip).As a result, it was not usable.The catheter was already connected to the wrong end in the packaging or during production.
Additional Manufacturer Narrative
Investigation summary: no product sample was received.Two (2) photos were attached to the complaint.On photos provided is observed through packaging that catheter is connected to the port.Per photos provided, complaint is confirmed as catheter is connected to port.Manufacturing process was reviewed by multidisciplinary team.Production personnel was interviewed due defect reported, where it was mentioned that manufacturing procedure has reference images for packaging that show catheter was preconnected to port.During the process review ncmr-tij-24-1092 was opened to continue further investigation and document corrective action.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
While performing a review of complaint file (b)(4), it was discovered that the file was inadvertently assessed as reportable.There was no patient death, no serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report reference number 9617604-2024-00775 is no longer considered reportable, please disregard any reports associated with it.

• Brand Name: DELTEC SUBCUTANEOUS CATHETER
• 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: 20352553
• Report Number: 9617604-2024-00775
• Device Sequence Number: 15453691
• Product Code: LJT
• UDI-Device Identifier: 10610586032646
• UDI-Public: (01)10610586032646(17)290319(10)6005959
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072657
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: 21-4425-24
• Device Lot Number: 6005959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 10/30/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/18/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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