MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC DELTEC GRIPPER PLUS NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2968-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon removal from the patient, the nurse pricked herself with the needle.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
B3: event date was entered.

• Brand Name: DELTEC GRIPPER PLUS NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9940825
• Report Number: 3012307300-2020-02946
• Device Sequence Number: 11595577
• Product Code: FPA
• UDI-Device Identifier: 10610586027765
• UDI-Public: 10610586027765
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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 Expiration Date: 11/12/2024
• Device Model Number: 21-2968-24
• Device Catalogue Number: 21-2968-24
• Device Lot Number: 3896397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1