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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 22G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN
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BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 22G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/04/2019
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 when saline solution was infused into the device before use, leakage was found from the tube.There was no reported patient involvement.
 
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Brand Name
WINGED INFUSION SET WITH INJECTION SITE 22G X 0.75IN
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8461645
Report Number3006260740-2019-00711
Device Sequence Number13788336
Product Code FMI
UDI-Device Identifier00801741065873
UDI-Public(01)00801741065873
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K863606
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/28/2019
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 Number2205222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2019
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2019
Initial Report FDA Received Date03/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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