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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 19G X 1 IN; NEEDLE, HYPODERMIC, SINGLE LUMEN
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BARD ACCESS SYSTEMS WINGED INFUSION SET 19G X 1 IN; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of redn2264 showed no other similar product complaint(s) from this lot number.
 
Event or Problem Description
It was reported that it is very difficult to connect the needle which leads to leakage.No other information was provided.
 
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Brand Name
WINGED INFUSION SET 19G X 1 IN
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10192510
Report Number3006260740-2020-02214
Device Sequence Number19059548
Product Code FMI
UDI-Device Identifier00801741037573
UDI-Public(01)00801741037573
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K863606
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/24/2020
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 Expiration Date12/31/2023
Device Model NumberN/A
Device Catalogue Number0604180
Device Lot NumberREDN2264
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2020
Initial Report FDA Received Date06/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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