MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot history review (lhr) of asdss0131 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdss0131) have been reported from the same facility in (b)(4).
Event or Problem Description
It was reported that the anti-reflux valve leaked.The patient had product on her arm.The team had to decontaminate it.It was stated that this event occurred with two patients.This report addresses the first patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 1 IN 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: 9035905
• Report Number: 3006260740-2019-02697
• Device Sequence Number: 2600363
• Product Code: FPA
• UDI-Device Identifier: 00801741066276
• UDI-Public: (01)00801741066276
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: LH-0034YN
• Device Lot Number: ASDSS0131
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1