MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH II PORT; PORT, CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS

Model Number	21-4055-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device leaked.No patient injury was reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.If the product is returned, will reopen this complaint for further investigation.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found no root cause could be determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.Initial reporter sent report to fda? unknown.No information has been received to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC PORT-A-CATH II PORT
• Common Device Name: PORT, CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• 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: 15453912
• Report Number: 3012307300-2022-19713
• Device Sequence Number: 15173860
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K962695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 08/04/2024
• Device Model Number: 21-4055-24
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 3860075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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: Unknown