MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 19MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rect0210 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that leakage from y-site during infusion of obinutuzumab 15 mins after the 2nd increment i.E.45 mins into the infusion.The patient has received 50mls/hr, and was running at 100mls/hr.The nurse returned to the patient as he had called his buzzer to say his shirt was wet and the pump was stopped.The patient had already received immunoglobulin a viscous fluid and the pre-medications for the obinutuzumab with no concerns.The connections on the two hubs of the port were vygon needle free connectors.The pressure default on the pump is set at 150 psi no amendments were made to this.The catheter was flushed with only a small amount of saline to ascertain where the leak was coming from and this was the y-site of the connection of the ez huber, blood could also be aspirated back to confirm patency before removing.It was stated patient top slightly wet, no leakage to skin.Patient changed into a hospital gown.Infusion was stopped, huber safety infusion set changed.The port was de-accessed and safety device activated and the patient reassessed again for the rest of the treatment to be administered.The estimated potential maximum calculated loss for of the monoclonal antibody (anti-cancer treatment) was 15mins worth of drug at a rate of 100mls/hr is 25 mls.

• Brand Name: EZ HUBER 22G X 19MM WITH 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: 8322933
• Report Number: 3006260740-2019-00194
• Device Sequence Number: 19359303
• Product Code: FPA
• UDI-Device Identifier: 00801741089343
• UDI-Public: (01)00801741089343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: SHG22-75Y
• Device Lot Number: RECT0210
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1