MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2019
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) of reau0707 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that leakage occurred between the lure connecter of the side injection tube and the infusion line.The infusion line was re-connected to the luer connector of main injection tube at y-site.After re-connected the line, the infusion could be completed without leaking.There was no reported patient injury.
Event or Problem Description
It was reported that leakage occurred between the lure connecter of the side injection tube and the infusion line.The infusion line was re-connected to the luer connector of main injection tube at y-site.After re-connected the line, the infusion could be completed without leaking.There was no reported patient injury.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 22G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8441844
• Report Number: 3006260740-2019-00621
• Device Sequence Number: 11494446
• Product Code: FMI
• UDI-Device Identifier: 00801741065903
• UDI-Public: (01)00801741065903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 2206222
• Device Lot Number: REAU0707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1