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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. DELTEC® GRIPPER PLUS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD; INC. DELTEC® GRIPPER PLUS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-3466-24
Medical Device Problem Code Retraction Problem (1536)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 10/04/2019
Type of Reportable Event Serious Injury
Event or Problem 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.
 
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Brand Name
DELTEC® GRIPPER PLUS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9235429
Report Number3012307300-2019-05917
Device Sequence Number411014
Product Code FPA
UDI-Device Identifier10610586033056
UDI-Public10610586033056
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K072657
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/24/2019
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 Health Professional
Device Expiration Date08/16/2024
Device Catalogue Number21-3466-24
Device Lot Number3854215
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2019
Initial Report FDA Received Date10/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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