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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER NON-CORING NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER NON-CORING NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2938-24
Medical Device Problem Code Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code Extravasation (1842)
Date of Event 05/25/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).Manufacturing/expiration date was unable to be found based on lot number provided by customer.
 
Event or Problem Description
User facility reported that an oncology patient with an implantable venous access system experienced infiltration of cytotoxic chemotherapy drug near the clavicular area (6 cm from access site) approximately 15 minutes after beginning infusion therapy.The extravasation site was imaged via contrast xray and evidence of kinking of the external connection at 5 cm at the clavicular level was found.Medical intervention was required to remove the catheter from the patient.No other patient or device details were provided.
 
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Brand Name
DELTEC® GRIPPER NON-CORING NEEDLE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7720089
Report Number3012307300-2018-02835
Device Sequence Number1015925
Product Code FPA
UDI-Device Identifier10610586023217
UDI-Public10610586023217
Combination Product (Y/N)N
Initial Reporter CountryCI
PMA/510(K) Number
K870866
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/25/2018
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 No Information
Device Catalogue Number21-2938-24
Device Lot Number333356
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2018
Initial Report FDA Received Date07/25/2018
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 Required Intervention;
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