MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 22G X 0.75IN WITH NF VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	583112
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.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 rebx1952 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebx1952) have been reported from the same facility.
Event or Problem Description
It was reported that the nurse found the device leaking from the connection of the tubing and the base plate when she attempted to flush with saline syringe prior to infusion.The nurse reported that this happened two times in the same patient.This report addresses the second event.

• Brand Name: SAFETY HUBER 22G X 0.75IN WITH NF VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7716057
• Report Number: 3006260740-2018-01813
• Device Sequence Number: 1753995
• Product Code: FPA
• UDI-Device Identifier: 00801741044885
• UDI-Public: (01)00801741044885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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 Catalogue Number: 583112
• Device Lot Number: REBX1952
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1