MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reep3322 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch: "patient accessed with bard portacath needle 22g 3/4-inch needle and when drawing blood air entered the line.All connections were tight but continued to draw air.Needle was removed and a new one was place and no problem." what problem did the user have: "device malfunction - that is, the device did not do what it was intended to do.".

• Brand Name: EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10617527
• Report Number: 3006260740-2020-03423
• Device Sequence Number: 19641505
• Product Code: FPA
• UDI-Device Identifier: 00801741089060
• UDI-Public: (01)00801741089060
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SH22-75YS
• Device Lot Number: REEP3322
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1