MAUDE Adverse Event Report: GRA SET V/NV QS MC 60D 3SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	10012564
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the gra set v/nv qs mc 60d 3ss experienced leakage.The following information was provided by the initial reporter: anesthesia has had issues with burette gravity sets mfr# (b)(4) leaking at the bottom of the chamber where the tubing hooks up to it.They are refusing to use any of the below product lot #.
Additional Manufacturer Narrative
H6: investigation: 5 unused samples were received and tested by our quality team with the customer's complaint of leakage.All samples were primed and infused with saline with no presentation of leak.The sets were then pulled at connections at a force which would be greater than that applied in regular medical use.There were still no leaks noticed and the customer's complaint cannot be verified and the root cause remains unknown.A device history record review for model 10012564 lot number 20106218 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 5th related complaint reported with the defect/condition of leakage with lot #20106218 regarding item #10012564.
Event or Problem Description
It was reported that the gra set v/nv qs mc 60d 3ss experienced leakage.The following information was provided by the initial reporter: anesthesia has had issues with burette gravity sets mfr# 10012564 leaking at the bottom of the chamber where the tubing hooks up to it.They are refusing to use any of the below product lot #.

• Brand Name: GRA SET V/NV QS MC 60D 3SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12277486
• Report Number: 9616066-2021-51704
• Device Sequence Number: 2871325
• Product Code: FPA
• UDI-Device Identifier: 50885403233744
• UDI-Public: 50885403233744
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: Other
• Device Expiration Date: 10/23/2023
• Device Model Number: 10012564
• Device Catalogue Number: 10012564
• Device Lot Number: 20106218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2020
• 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