MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP SAFETY INFUSION SET 20G X 0.75 INCH WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 reds3003 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported via medwatch "patient arrived for chemo disconnect, noticed white powder type substance/residue on port extension and patient's chest/breast area.Substance appeared to be crystalized 5 fu chemo.When port was flushed with ns and heparin it leaked via the y site valve.Patient called when he arrived home after checking shirt he wore previous day and that also had white residue on it.".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds3003 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "patient arrived for chemo disconnect, noticed white powder type substance/residue on port extension and patient's chest/breast area.Substance appeared to be crystalized 5 fu chemo.When port was flushed with ns and heparin it leaked via the y site valve.Patient called when he arrived home after checking shirt he wore previous day and that also had white residue on it.".

• Brand Name: SAFESTEP SAFETY INFUSION SET 20G X 0.75 INCH 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: 9306172
• Report Number: 3006260740-2019-03516
• Device Sequence Number: 16670140
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: CPA00019B
• Device Lot Number: REDS3003
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 110