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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN
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BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 2206220
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.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 that before using the port needle the doctor flushed the needle and found that there was a leakage on the tubing.The device was not used.
 
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Brand Name
WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7675927
Report Number3006260740-2018-01667
Device Sequence Number1554778
Product Code FMI
UDI-Device Identifier00801741065897
UDI-Public(01)00801741065897
Combination Product (Y/N)N
PMA/510(K) Number
K863606
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/10/2018
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 Number2206220
Device Catalogue Number2206220
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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