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

Model Number	21-2966-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was in use with patient and device showed air in the tubing.No adverse effects reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A product sample and picture was received for evaluation.Visual and functional testing were performed.From pictures no air in line is observed, a point of blood is observed.No air was detected in the 4 samples evaluated; no problem is observed with the functionality of the product.The complaint is not confirmed.Based on the analysis conducted in the sample provided, the complaint was not confirmed.No corrective actions were taken since the complaint was not confirmed.No problems or issues were identified during this device history record review.

• Brand Name: DELTEC GRIPPER HUBER NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 11649270
• Report Number: 3012307300-2021-03067
• Device Sequence Number: 3356616
• Product Code: FPA
• UDI-Device Identifier: 10610586027741
• UDI-Public: 10610586027741
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021999
• 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,Followup
• Report Date (Section B): 05/02/2023

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: 21-2966-24
• Device Catalogue Number: 21-2966-24
• Device Lot Number: 4057906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 08/07/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown