MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G 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	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recu1419 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, " in the isolated patient, the port needle was connected to nacl.Afterward, the nurse left the room.After about 1 hour, the nurse noticed that the infusion has completely run out.It dripped at the connection between luer and infusion line.".

• Brand Name: HUBER PLUS 20G 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: 8659899
• Report Number: 3006260740-2019-01543
• Device Sequence Number: 291315
• Product Code: FPA
• UDI-Device Identifier: 00801741065552
• UDI-Public: (01)00801741065552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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: 012001
• Device Lot Number: RECU1419
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1