MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 20G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the winged infusion set was leaking by the yellow piece.No other information was provided.
Additional Manufacturer Narrative
The complaint was initially assessed as a reportable event.Review of the event details and results of the investigation confirmed that a reportable event had not occurred.
Event or Problem Description
It was reported that the winged infusion set was leaking by the yellow piece.No other information was provided.

• Brand Name: WINGED INFUSION SET 20G 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 Key: 8689159
• Report Number: 3006260740-2019-01617
• Device Sequence Number: 2299320
• Product Code: FMI
• UDI-Device Identifier: 00801741065804
• UDI-Public: (01)00801741065804
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 0604190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1