MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2206220
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reey3563 showed two other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported that at the point of attachment at port needle and dosifix/safeset ,there was leak observed of fluid.Patient completed therapy using 2nd needle.It was reported this occurred with two devices.This report addresses the first device.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12455198
• Report Number: 3006260740-2021-03770
• Device Sequence Number: 3964223
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 2206220
• Device Catalogue Number: 2206220
• Device Lot Number: REEY3563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other