MAUDE Adverse Event Report: BD ALARIS¿ INFUSION PUMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	22000-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: the state was determined based on the area code within the provided phone #.Investigation summary: a complaint of tubing collapsing during infusion was received from the customer.No product or photo was returned by the customer.The customer complaint of defective tubing could not be verified due to the product not being returned for failure investigation.A device history record review for model 22000-b007t lot number 21035504 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19feb2021.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that at least one bd alaris¿ infusion pump experienced defective tubing.The following information was provided by the initial reporter: while administration of the medication, the tubing is collapse and so it prevent administrating the rest of the medication to the patient.It happened several time, today is one of the day that happened.

• Brand Name: BD ALARIS¿ INFUSION PUMP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12677381
• Report Number: 9616066-2021-52292
• Device Sequence Number: 4471080
• Product Code: FPA
• UDI-Device Identifier: 50885403245020
• UDI-Public: 50885403245020
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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
• 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: 03/19/2024
• Device Model Number: 22000-B007T
• Device Catalogue Number: 22000-B007T
• Device Lot Number: 21035504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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