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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 20GX 0.75¿ W/ Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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SAFESTEP HUBER NEEDLE SET 20GX 0.75¿ W/ Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asezf049 showed no other similar product complaint(s) from this lot number. Device not returned for evaluation.
 
Event Description
It was reported via medwatch "during etoposide/ns post hydration the patient called the primary nurse to his side to inform that something was "leaking". Inspection and evaluation, revealed that fluid was leaking from the proximal port (blue) of the needle tubing the fluid that leaked out was estimated to be less than 5ml, chemical spill/leak policy followed. There was no signs/symptom/concern of medication infiltration. The faulty needle was removed and disposed of and the port was accessed again via sterile technique. Brisk blood return noted and ns post hydration completed without incidence. ".
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20GX 0.75¿ W/ Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12684917
MDR Text Key278094219
Report Number3006260740-2021-04481
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0031YN
Device Lot NumberASEZF049
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2021 Patient Sequence Number: 1
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