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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
Device Problems Defective Component (2292); Installation-Related Problem (2965); Material Split, Cut or Torn (4008)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/27/2020
Event Type  malfunction  
Event 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 NameSET ADMINISTRATION INTRAVASCULAR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC
6000 lane n
minneapolis, mn
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
ave calidad no. 4,
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
dave halverson
6000 lane n
minneapolis, mn 
3833310
MDR Report Key10235453
MDR Text Key197671366
Report Number3012307300-2020-06685
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNDL, GRIPPER MICRO, 22G X .75 12/BOX
Device Catalogue Number21-3251-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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