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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUBER PLUS 20G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR
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HUBER PLUS 20G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Activation Problem (4042)
Health Effect - Clinical Code Needle Stick/Puncture (2462)
Date of Event 07/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported that the patient has finished the treatment and the nurse removes the needle.When it is discarded, the safety valve bounces, causing the nurse to stick the needle.Patient have completed the treatment.Facility perform blood datas about hepatitis b, hiv and syphilis follow up.Both of patient and nurse are currently negative.
 
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Brand Name
HUBER PLUS 20G X 0.75"
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12373832
Report Number3006260740-2021-03550
Device Sequence Number14482052
Product Code FPA
UDI-Device Identifier00801741065620
UDI-Public(01)00801741065620
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K993848
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/05/2021
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 Number012034
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date08/26/2021
Was Device Evaluated by Manufacturer? (Y/N) No
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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