MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
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 that during the use winged infusion set they found that the blue colored tube connected to 3 way stopcok was broken hence leakage.

• 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 Key: 8607467
• Report Number: 3006260740-2019-01370
• Device Sequence Number: 11336436
• Product Code: FMI
• UDI-Device Identifier: 00801741065897
• UDI-Public: (01)00801741065897
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• 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): 05/14/2019

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 Number: N/A
• Device Catalogue Number: 2206220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1