MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3367-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was placed in use with patient in home care for infusion of fluorouracil.The reporter stated the patient identified leakage where the needle met the portal.The patient reported to emergency department.No further adverse effects to patient reported.

• Brand Name: DELTEC GRIPPER NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10624362
• Report Number: 3012307300-2020-10112
• Device Sequence Number: 11553089
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: 10610586033001
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2020

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: Lay User/Patient
• Device Expiration Date: 04/16/2025
• Device Model Number: 21-3367-24
• Device Catalogue Number: 21-3367-24
• Device Lot Number: 3971763
• 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: 09/17/2020
• Initial Report FDA Received Date: 10/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization