MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 20G X 0.75IN WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 redt0573 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after accessing the port, leakage was noted from the needle during infusion.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting a 20ga x 0.75¿ ez huber safety infusion set with y-site.The device appeared free of obvious usage residues and the safety mechanism was not engaged.The valved y-site was circled in red in the photograph and labeled ¿leak¿.No damage or leaking was observed in the supplied photograph.Consequently this complaint is inconclusive at this time.
Event or Problem Description
It was reported that after accessing the port, leakage was noted from the needle during infusion.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: 8874886
• Report Number: 3006260740-2019-02334
• Device Sequence Number: 2548416
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: REDT0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1