MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 20G X 0.75IN 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu0763 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the ez huber safety infusion set leaked at the blue y-site valve.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a fluid forming at the blue valve is confirmed but the exact cause remains unknown.One 20 ga x ez huber w/y-site infusion set was returned for investigation.The product packaging showed ref: shw20-75ys and lot: redu0763.The sample was returned with the safety mechanism fully activated.One video sample of a y-site valved connector was also provided for evaluation.The proximal extension leg was observed to have a yellow clamp over the tubing.The device appears to be having the pressure manipulated.Red fluid is observed to show around to blue valve when pressurized and then withdraw back when the pressure is relieved.A continuous flow or leak was not observed.The returned physical sample was functionally tested.The sample was flushed with water using a 12 ml syringe and no leaks were observed.The sample was flushed using additional pressure and a bead of fluid formed at the y-site blue valve.A continuous leak was not observed.Since fluid was observed to form at the blue valve, the complaint is confirmed but the exact cause remains unknown.The product ifu cautions, ¿high pressure or use with power injectors may cause leakage or damage.¿ a lot history review (lhr) of redu0763 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the ez huber safety infusion set leaked at the blue y-site valve.No other information was provided.

• Brand Name: EZ HUBER 20G X 0.75IN 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: 9267034
• Report Number: 3006260740-2019-03433
• Device Sequence Number: 19394193
• Product Code: FPA
• UDI-Device Identifier: 00801741089879
• UDI-Public: (01)00801741089879
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: SHW20-75YS
• Device Lot Number: REDU0763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1