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 Codes	No Consequences Or Impact To Patient (2199); 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 four other similar product complaint(s) from this lot number.The complaints for this lot number (redt0573) have been reported from the same facility.
Event or Problem Description
It was reported that the huber needle leaked at the port.No other information 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 leak at the y-site is confirmed but the exact cause remains unknown.One 20 ga x 0.75 in ez huber infusion set w/ysite was returned for investigation.One photo sample of a y-site blue valve connector was provided for evaluation.The clamp was shown to be engaged.A reddish fluid can be observed within the y site hub and distal extension tubing.No apparent damage can be seen on the device.Fluid can be seen to be present on the surface of the blue valve.The proximal luer and needle housing are not shown in the photo.Microscopic observation of the blue valve revealed dried blood residue.The sample was flushed through the y-site connector.No leaks were observed.Additional flushing and pressurization through the proximal connector resulted in a bead of water forming at the blue valve.A continuous leak was not observed.High pressures or use with power injectors may cause leakage.Since the sample was observed to form a bead during pressurization and the conditions during use are unknown, the exact cause could not be determined.A lot history review (lhr) of redt0573 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (redt0573) have been reported from the same facility.
Event or Problem Description
It was reported that the huber needle leaked at the port.No other information provided.
Event or Problem Description
It was reported that the huber needle leaked at the port.No other information provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak at the port is confirmed; however the exact cause could not be determined from the photo sample provided.One photo sample of a y-site blue valve connector was provided for evaluation.The clamp was shown to be engaged.A reddish fluid can be observed within the y site hub and distal extension tubing.No apparent damage can be seen on the device.Fluid can be seen on the surface of the blue valve which suggest the valve may have leaked fluid.The proximal luer and needle housing are not shown in the photo.It is unknown if the sample is being pressurized from the proximal connector.The product instructions for use (ifu) states, "high pressure or use with power injectors may cause leakage or damage.".

• 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: 8952349
• Report Number: 3006260740-2019-02572
• Device Sequence Number: 2687769
• 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,Followup
• Report Date (Section B): 12/09/2019

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: 11/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 12/05/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/27/2019; 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1