MAUDE Adverse Event Report: ST PAUL DELTEC; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION

Model Number	21-4083-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned, unable to confirm product complaint.
Event or Problem Description
It was reported that the needle of the implantable intravenous drug delivery system was bent.The needle will not go into the patients port.The hospital analyzed the cause of the incident and was unable to determine.It was replaced.
Additional Manufacturer Narrative
Other, other text: h10 correction: device manufacture date and expiration date were added.Information was inadvertently missed on previous submission.

• Brand Name: DELTEC
• Common Device Name: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION
• 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; yishan town; minneapolis, MN 55442
• MDR Report Key: 13030946
• Report Number: 3012307300-2021-13016
• Device Sequence Number: 4394621
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2025
• Device Model Number: 21-4083-24
• Device Lot Number: 3957606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown