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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asfnf008 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asfnf008) have been reported from the same facility in (b)(6).Device not returned for evaluation.
 
Event or Problem Description
It was reported that on two occasions the tubes of the safestep needles have split at various points on the device.No other information was provided.This report addresses the first occasion.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 19G X 0.75IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12343072
Report Number3006260740-2021-03401
Device Sequence Number4381414
Product Code FPA
UDI-Device Identifier00801741066245
UDI-Public(01)00801741066245
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K153440
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0033
Device Lot NumberASFNF008
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2021
Initial Report FDA Received Date08/19/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured01/01/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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