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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 20G X 1 IN; NEEDLE, HYPODERMIC, SINGLE LUMEN
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BARD ACCESS SYSTEMS WINGED INFUSION SET 20G X 1 IN; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Catalog Number 0604200
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/09/2020
Type of Reportable Event Serious Injury
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 the needle was placed 3 days in a chamber in subclavian position and it broke at a right angle.The right part of the needle was found under the skin which require surgical intervention to extract and suture it.No other information was provided.
 
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Brand Name
WINGED INFUSION SET 20G 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 Key10351139
Report Number3006260740-2020-02732
Device Sequence Number2329370
Product Code FMI
UDI-Device Identifier00801741065811
UDI-Public(01)00801741065811
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 company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Catalogue Number0604200
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2020
Initial Report FDA Received Date07/31/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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