MAUDE Adverse Event Report: ST PAUL DELTEC PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYST; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS,

Model Number	21-4155-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device was installed in patient on (b)(6) 2019.On (b)(6) 2019, problems were detected after the device was punctured, detecting filtration.Chest x-ray performed.Upon removal of device, it was found that the base was not attached to the rest of the reservoir.A new device was installed.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The one (1) picture was received and can be observed that the port which is inserted is detached from the housing.The sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination.The insert is loose and it can remove from the housing; the septum was collocated in the right position but it does not exceeds the surface of the housing.No marks of the detached of weld were detected inside the housing nor around the inner side of the insert.The most probably root causes are lack of knowledge of the operation of the welding machine and lack of process controls in the ultrasonic machine.The operator does not detect that the port was not welded.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYST
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS,
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15327571
• Report Number: 3012307300-2022-17007
• Device Sequence Number: 17763566
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: 10610586012594
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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 Expiration Date: 10/16/2023
• Device Model Number: 21-4155-24
• Device Catalogue Number: 21-4155-24
• Device Lot Number: 3717706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White