MAUDE Adverse Event Report: ST PAUL DELTEC; GRIPPER

Model Number	1.9MM,
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Infection, Direct (2244)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information from (b)(6) on a deltec port a cath.Patient had a deltec port-a-cath power pac inserted for antineoplastic therapy administration by a interventional radiology (b)(6) 2019.Port used for treatment until (b)(6) 2019.On (b)(6) 2020 patient presented with localized infection of port site, with nil preceding trauma.Port had not been accessed for 12 months prior to spontaneous development of infection.Port-a-cath surgically removed due to localized infection on (b)(6) 2020.

• Brand Name: DELTEC
• Common Device Name: GRIPPER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11211129
• Report Number: 3012307300-2021-00621
• Device Sequence Number: 3607016
• Product Code: LJT
• UDI-Device Identifier: 10610586032790
• UDI-Public: 10610586032790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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 Model Number: 1.9MM,
• Device Catalogue Number: 21-4485-24
• Device Lot Number: 3765323
• 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: 12/23/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1