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

Catalog Number 21-3466-24

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/04/2019

Event Type  Injury  

Event Description

Information was received indicating that following flushing the port and removal of the a smiths medical deltec® gripper plus® needle, the safety failed to deploy.Subsequently, the clinician received a needle stick to the thumb.The needle stick protocol was performed along with a tetanus shot administration.There were no further adverse effects reported.

• Brand Name: DELTEC® GRIPPER PLUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9235429
• MDR Text Key: 163745437
• Report Number: 3012307300-2019-05917
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586033056
• UDI-Public: 10610586033056
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-3466-24
• Device Lot Number: 3854215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention