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

Catalog Number	21-4052-24
Medical Device Problem Codes	Crack (1135); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples were returned.The customer provided one (1) photo where it is possible to see the defect.According to the photo provided by the customer, the failure mode ¿a0133 - damaged/broke/broken¿ reported in the complaint was confirmed since in the photo can be appreciated the end of the catheter is cracked.However, no root cause could be determined since no sample was received.In case the sample is provided the complaint will be re-opened to evaluate the device and make the corresponding tests.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.
Event or Problem Description
It was reported that the irrigation cannula was connected to the catheter, and when aspiration occurred, air came back instead of liquid.They noticed that the end of the catheter was cracked.The device was operated by the physician.The event occurred intraoperatively; there was patient involvement, and no patient harm/adverse event reported.

• Brand Name: DELTEC STANDARD PAC LL IMPLANTABLE PORT KIT
• 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: 20915341
• Report Number: 9617604-2024-00932
• Device Sequence Number: 12709751
• Product Code: LJT
• UDI-Device Identifier: 10610586023521
• UDI-Public: (01)10610586023521(17)271111(10)4343087
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: 21-4052-24
• Device Lot Number: 4343087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2022
• 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