MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 19G X 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting a 19ga x 1¿ winged infusion set with y-site.The depicted device appeared free of obvious usage residues.The needle cover was in place.Caps were attached to both luer adapters.The device was placed on a paper with a drawn arrow pointing to the extension tubing just distal of the luer adapter.No leakage or damage was observed during examination of the submitted photograph; however, the device could not be thoroughly examined or functionally tested.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of redx4352 showed three other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there has been leakage at the needle tubing with multiple devices.It is unknown the number of devices at this time.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 19G 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: 9826388
• Report Number: 3006260740-2020-00853
• Device Sequence Number: 3086621
• Product Code: FMI
• UDI-Device Identifier: 00801741065880
• UDI-Public: (01)00801741065880
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 2206219
• Device Lot Number: REDX4352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1