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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 04/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.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 leakage of cytostatic preparations.It was stated, "needle leaking at the connection or needle is very difficult to connect.The material we connect with is of no importance.The problem occurs with the syringes, microclave or trousses.The problem is really at the connection point of the needles.".
 
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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 Key9984250
Report Number3006260740-2020-01472
Device Sequence Number19603559
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) 04/21/2020
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 Model NumberN/A
Device Catalogue Number0604180
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/02/2020
Initial Report FDA Received Date04/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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