MAUDE Adverse Event Report: ST PAUL DELTEC; IMPLANT PORT

Model Number	21-4071-24
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical implantable ports|deltec port-a-cath ii ports required intervention of surgical removal.Reported two months after the port was installed, the patient felt swelling.The doctor took out the port, and found that there were cracks around the catheter.Photo attached.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC
• Common Device Name: IMPLANT PORT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12033831
• Report Number: 3012307300-2021-06332
• Device Sequence Number: 3975698
• Product Code: LJT
• UDI-Device Identifier: 10610586017841
• UDI-Public: 10610586017841
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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 Expiration Date: 11/04/2021
• Device Model Number: 21-4071-24
• Device Catalogue Number: 21-4071-24
• Device Lot Number: 3349911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown