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

Model Number	10013072
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of leakage was received from the customer.A photo of the material number information was provided by the customer.The customer defect could not be confirmed as a photo of the defect or a physical sample was not returned for investigation.A device history record review could not be performed on model 10013072 because an invalid lot number was provided by the customer.Populated material # 24600-0007.A root cause could not be determined as a sample was not sent in and a full investigation could not be completed.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: a photo of the material number information was provided by the customer.The customer defect could not be confirmed as a photo of the defect or a physical sample was not returned for investigation.A root cause could not be determined as a sample was not sent in and a full investigation could not be completed.
Event or Problem Description
It was reported that the bd alaris¿ infusion set experienced leakage.The following information was provided by the initial reporter: the blue plastic piece that sits above where the tubing is inserted into the pup was dripping the chemo.I had a rn tell me that she recently had an issue when she opened the tubing, that it appeared to be dry rotted.I was not made aware when she noticed it.

• Brand Name: BD ALARIS¿ INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12752026
• Report Number: 9616066-2021-52369
• Device Sequence Number: 14592716
• Product Code: FPA
• UDI-Device Identifier: 37613203021228
• UDI-Public: 37613203021228
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/14/2021

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 Model Number: 10013072
• Device Catalogue Number: 10013072
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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