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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2762-24
Medical Device Problem Codes Leak/Splash (1354); Unstable (1667)
Health Effect - Clinical Code Sepsis (2067)
Date of Event 09/20/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a smiths medical deltec® gripper plus® safety needle was unable to be stabilized resulting in medication leaking.The patient was reported to go into septic shock requiring two port-a-cath change outs; leading to a prolonged hospitalization course.No further patient adverse effects were reported.
 
Event or Problem Description
It was additionally reported that the current state of the patient was "well and controlled".Antibiotics were administered.
 
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Brand Name
DELTEC® GRIPPER PLUS® SAFETY NEEDLES
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6918357
Report Number3012307300-2017-02159
Device Sequence Number1312178
Product Code FPA
UDI-Device Identifier10610586025556
UDI-Public10610586025556
Combination Product (Y/N)N
Initial Reporter CountryBR
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,Followup
Report Date (Section B) 12/14/2017
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? No
Operator of Device Nurse
Device Expiration Date08/28/2021
Device Catalogue Number21-2762-24
Device Lot Number36X858
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2017
Supplement Date Received by Manufacturer10/24/2017
Initial Report FDA Received Date10/05/2017
Supplement Report FDA Received Date12/14/2017
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 Hospitalization; Required Intervention;
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