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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GRIPPER PLUS SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR,
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SMITHS MEDICAL ASD, INC. 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 No Consequences Or Impact To Patient (2199)
Date of Event 05/06/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer has not yet 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.Device not available for return.
 
Event or Problem Description
It was reported that during use the needle would not engage into the safety mechanism.No adverse health outcome resulted from this event.
 
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Brand Name
GRIPPER PLUS SAFETY NEEDLE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR,
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
1265 grey fox rd.
st. paul MN 55112
MDR Report Key5686691
Report Number2183502-2016-01125
Device Sequence Number214441
Product Code FPA
UDI-Device Identifier30610586027738
UDI-Public30610586027738
Combination Product (Y/N)N
Initial Reporter CountryAS
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 Nurse
Type of Report Initial
Report Date (Section B) 05/27/2016
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 Other
Device Expiration Date02/28/2021
Device Catalogue Number21-2965-24
Device Lot Number36X084
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/06/2016
Initial Report FDA Received Date05/27/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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