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

Model Number 21-2966-24

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

It was reported the device was used to access patient's portal and the user could not aspirate blood but could not- air bubbles were seen.No adverse effects reported.

• Brand Name: DELTEC GRIPPER PLUS HUBER NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11817319
• MDR Text Key: 250370486
• Report Number: 3012307300-2021-04300
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027741
• UDI-Public: 10610586027741
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2966-24
• Device Catalogue Number: 21-2966-24
• Device Lot Number: 4060770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1