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	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
" a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.".
Event or Problem Description
It was reported that a gra set v/nv qs mc 60d 3ss experienced component separation and leakage during use.The following was reported by the initial reporter: "the bottom of the tube would either leak really bad or just pop off like there is no glue on it.They did check the product prior to spiking the iv and stated it seemed to be fine, but after the iv fluid sat in there for a little bit the bottom came off or started leaking really bad.".
Additional Manufacturer Narrative
H.6.Investigation: due to no photo or sample being received, the customer's complaint of separation could not be confirmed 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 1st related complaint reported with the defect/condition of leakage with lot #20106218 regarding item #10012564.
Event or Problem Description
It was reported that a gra set v/nv qs mc 60d 3ss experienced component separation and leakage during use.The following was reported by the initial reporter: "the bottom of the tube would either leak really bad or just pop off like there is no glue on it.They did check the product prior to spiking the iv and stated it seemed to be fine, but after the iv fluid sat in there for a little bit the bottom came off or started leaking really bad.".

• Brand Name: GRA SET V/NV QS MC 60D 3SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11925071
• Report Number: 9616066-2021-51237
• Device Sequence Number: 19062936
• Product Code: FPA
• UDI-Device Identifier: 50885403233744
• UDI-Public: 50885403233744
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Expiration Date: 10/23/2023
• Device Model Number: 10012564
• Device Catalogue Number: 10012564
• Device Lot Number: 20106218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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