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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2965-24
Medical Device Problem Code Protective Measures Problem (3015)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 04/11/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event or Problem Description
It was reported that a deltec® gripper plus® safety needle did not engage into the safety device.The needle had been put on the care plate, and while the nurse took the compress, the needle pricked the nurse.The nurse went through accidental blood exposure protocol.No permanent injury to patient or clinician was reported.
 
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Brand Name
DELTEC® GRIPPER PLUS® SAFETY NEEDLE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6573157
Report Number3012307300-2017-01051
Device Sequence Number13619341
Product Code FPA
UDI-Device Identifier10610586027734
UDI-Public10610586027734
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K021999
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 05/17/2017
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 Nurse
Device Catalogue Number21-2965-24
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/25/2017
Initial Report FDA Received Date05/17/2017
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 Other;
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