MAUDE Adverse Event Report: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MPX5304-C
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint of a set missing a blue clamp was received from the customer.No product or photo was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review for model mpx5304-c lot number 20075809 was performed.The search showed that a total of (b)(4) units in 2 lot numbers was built on 15jul2020.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.
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set was missing the blue clamp.The following information was provided by the initial reporter: "bd max-plus pressure rate extension set with clear needleless connector and y-site: it was missing the blue clamp.I did not use it on the pt.".

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12712638
• Report Number: 9616066-2021-52323
• Device Sequence Number: 4489199
• Product Code: FPA
• UDI-Device Identifier: 50885403237247
• UDI-Public: 50885403237247
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 09/30/2021

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: 07/15/2025
• Device Model Number: MPX5304-C
• Device Catalogue Number: MPX5304-C
• Device Lot Number: 20075809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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