MAUDE Adverse Event Report: MANIFOLD W/EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 10010903

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the manifold w/ext set had flow issues with propofol during the infusion.The following information was provided by the initial reporter: "anesthesiologist complained of the medication (propofol) backing up the line into the blood set when they were pushing the medication in the one way valves.The set they are complaining about is the 20511e extension set.They attach this set to the 10010903 blood set (no issue with this set); but when they attach the syringe and push the meds into the one way valve, it is not only going to the patient, but up the line as well.".

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that as they were pushing the medication into the one way valves, propofol was backing up the line into the blood set.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20511e because a lot number was not provided by the customer.A device history record review could not be performed on model 10010903 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the manifold w/ext set had flow issues with propofol during the infusion.The following information was provided by the initial reporter: "anesthesiologist complained of the medication (propofol) backing up the line into the blood set when they were pushing the medication in the one way valves.The set they are complaining about is the 20511e extension set.They attach this set to the 10010903 blood set (no issue with this set); but when they attach the syringe and push the meds into the one way valve, it is not only going to the patient, but up the line as well.".

• Brand Name: MANIFOLD W/EXT SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12351666
• MDR Text Key: 267644369
• Report Number: 9616066-2021-51861
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020887
• UDI-Public: 37613203020887
• Combination Product (y/n): N
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1