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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC SET ADMINISTRATION INTRAVASCULAR; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD,INC SET ADMINISTRATION INTRAVASCULAR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number NDL, GRIPPER MICRO, 22G X .75 12/BOX
Medical Device Problem Codes Defective Component (2292); Installation-Related Problem (2965); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 05/27/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information received a smiths medical implantable ports|deltec gripper micro needle caused needle stick to nurse.This event was described when removing and introducing needle, the nurse felt a prick on hand and noticed the device had split into two pieces; exposing with splash of blood.It was reported nurse was injured but no further detailed information.
 
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Brand Name
SET ADMINISTRATION INTRAVASCULAR
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC
6000 lane n
minneapolis, mn
MDR Report Key10235453
Report Number3012307300-2020-06685
Device Sequence Number13601887
Product Code FPA
UDI-Device Identifier10610586029745
UDI-Public10610586029745
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K072059
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/06/2020
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 Date10/05/2024
Device Model NumberNDL, GRIPPER MICRO, 22G X .75 12/BOX
Device Catalogue Number21-3251-24
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/09/2020
Initial Report FDA Received Date07/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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