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

Catalog Number	21-4455-24
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the input was delivered for surgery (7.8fr was requested), inside the pavilion they opened it and the doctor installed it, when he had the device, he noticed that the measurement did not match and checked the packaging.There they noticed that the envelope that came inside the box was a different size (5.8fr) and did not match what the box indicated.Since the device was already installed in the patient, they left it.According to the form, the product was used only once.One picture was provided by the customer showing a box with the label of the product.The event was classified as an adverse event, an incorrect measuring device was installed on the patient.This event happened in two surgeries with the same doctor and one patient involved in this event.Informing that there was no damage to the patient, but a measure that was not what the doctor wanted was installed.The product is currently installed in the patient.

• Brand Name: POWER PORT-A-CATH II
• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20296544
• Report Number: 9617604-2024-00755
• Device Sequence Number: 7199688
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: (01)10610586032707(17)280411(10)4437262
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 4437262
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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