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	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bottom of the gra set v/nv qs mc 60d 3ss buretrol separated from the container when pressure was used on it.The following information was provided by the initial reporter: "the white bottom of the buretrol separates from the container when pressure is applied.".
Event or Problem Description
It was reported that the bottom of the gra set v/nv qs mc 60d 3ss buretrol separated from the container when pressure was used on it.The following information was provided by the initial reporter: "the white bottom of the buretrol separates from the container when pressure is applied.".
Additional Manufacturer Narrative
H.6.Investigation: the customer reported the white bottom of the buretrol separates from the container, and returned 31 unopened samples of the same lot #20106218 model #10012564.The samples clearly separated at the bottom of the burette where the lower drip chamber connects, and the complaint is verified.There is little to no solvent on the connection, and some have even separated in the bag before being opened or used at all.There were 10 failures within the 31 samples, all of which were the same little to no solvent.No other failure modes were observed.The root cause is insufficient solvent applied during the assembly process.Manufacturing was contacted about the failure, and their investigation found two possible root causes for assembly issue, based mostly on new employees handling the process.The employees have been re-trained and necessary steps were taken to ensure a more consistent assembly process.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.The root cause is insufficient solvent.A complaint history check was performed and this is the 4th related complaint reported with the defect/condition of separation other component - no leak with lot #20106218 regarding item #10012564.H3 other text : see h.10.

• Brand Name: GRA SET V/NV QS MC 60D 3SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11968611
• Report Number: 9616066-2021-51288
• Device Sequence Number: 11663848
• 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): 07/21/2021

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: 05/20/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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