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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
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem Extravasation (1842)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Manufacturing/expiration date was unable to be found based on lot number provided by customer.
 
Event 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 NameDELTEC® GRIPPER NON-CORING NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7720089
MDR Text Key115027790
Report Number3012307300-2018-02835
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K870866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-2938-24
Device Lot Number333356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/25/2018 Patient Sequence Number: 1
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