MAUDE Adverse Event Report: GRAVITY SET V/NV CKV 3SS 10DP; INTRAVASCULAR ADMINISTRATION SET

Model Number	41134E
Medical Device Problem Codes	Backflow (1064); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 gravity set v/nv ckv 3ss 10dp tubing allowed blood to backflow through the access port during use.The following information was provided by the initial reporter: "on friday, (b)(6) i received a call from anesthsia about iv tubing that had allowed blood to back up and come out of one of the access ports.".
Additional Manufacturer Narrative
The following fields were updated due to corrected information: device available for eval?: no.Returned to manufacturer on: na.Investigation: no product or photo was returned by the customer.The customer complaint that the tubing had allowed backflow of blood when in use could not be verified due to the product not being returned for failure investigation.A device history record review for model 41134e lot number 21039516 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - back flow with lot #21039516 regarding item #41134e.
Event or Problem Description
It was reported that the gravity set v/nv ckv 3ss 10dp tubing allowed blood to backflow through the access port during use.The following information was provided by the initial reporter: "on friday, july 9, i received a call from (b)(6) about iv tubing that had allowed blood to back up and come out of one of the access ports.".

• Brand Name: GRAVITY SET V/NV CKV 3SS 10DP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12294682
• Report Number: 9616066-2021-51740
• Device Sequence Number: 3806872
• Product Code: FPA
• UDI-Device Identifier: 50885403235281
• UDI-Public: 50885403235281
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 08/25/2021

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: 03/10/2024
• Device Model Number: 41134E
• Device Catalogue Number: 41134E
• Device Lot Number: 21039516
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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