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 redt1683 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redt1683) have been reported from the same facility.
Event or Problem Description
It was reported the needles are leaking blood at y-port after flush.The facility reported three devices.This report addresses the third device.
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 hub leak is confirmed but the exact cause remains unknown.One 20 ga x 0.75 in ez huber infusion was returned in opened packaging with product information ref: shw20-75ys and lot: redt1683.Three additional product label lids were returned with product information ref: shw20-75ys and lot: redt1683.One product lid was returned with product information ref: shw20-75ys and lot: redt0573.Microscopic observation of the y site valve revealed no apparent damage.The sample was flushed from both luer connectors with water using a 12 ml syringe and was found to be patent to infusion.The distal clamp was activated in order to pressurize the device using the proximal connector.A bead of water with red residue was observed to form at the blue valve.Based on the condition of the sample returned, possible contributing factors include exposure to high pressures.The product ifu cautions, ¿high pressure or use with power injectors may cause leakage or damage.¿ a lot history review (lhr) of redt1683 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redt1683) have been reported from the same facility.
Event or Problem Description
It was reported the needles are leaking blood at y-port after flush.The facility reported three devices.This report addresses the third device.

• 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: 9121055
• Report Number: 3006260740-2019-02841
• Device Sequence Number: 19419849
• 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): 10/22/2019

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: REDT1683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1