MAUDE Adverse Event Report: EZ HUBER 20G X 15MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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 reez3291 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer via distributor: "the needle is leaking at the end piece." additional information received aug 25 2021: it was reported the defective needle was freshly placed without the defect being discovered.The leak was discovered during subsequent rinsing with saline solution.Consequences for the patient: a new port had to be used.

• Brand Name: EZ HUBER 20G X 15MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12455763
• Report Number: 3006260740-2021-03777
• Device Sequence Number: 3964226
• Product Code: FPA
• UDI-Device Identifier: 00801741089671
• UDI-Public: (01)00801741089671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: SHN20-60
• Device Lot Number: REEZ3291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other