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 redp0333 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp0333) have been reported from the same facility.
Event or Problem Description
It was reported that the needle was leaking at the port hub and tubing leg connection with first use/access.
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 was confirmed and the cause appears to b manufacturing related.One 20 ga x 0.75 in w/ysite ez huber safety infusion set was returned for investigation.The product label was returned with lot: redp0333.An injection cap was returned attached to the proximal luer connector.The sample was flushed with water using a 12 ml syringe and no leaks were observed.The safety mechanism was removed in order to occlude the distal end of the needle.The sample was pressurized with air and submerged in water.A leak at the connection between the extension tubing and needle hub was observed.Microscopic observation of the leak location revealed an uneven adhesive fillet between the extension tubing and the needle hub.Internal fissures were observed on the plastic needle housing along the distal end of the extension tubing.The cause of the fissures is unknown and appear to be contribute to the formation of a fluid path towards the leak location.An awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of redp0333 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp0333) have been reported from the same facility.
Event or Problem Description
It was reported that the needle was leaking at the port hub and tubing leg connection with first use/access.

• 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: 8745969
• Report Number: 3006260740-2019-01827
• Device Sequence Number: 14038134
• 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): 08/21/2019

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: REDP0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1