MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9265
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microbore bi-fuse extension set, 2 iv co the tubing separated from the luer.There was no report of patient impact.The following information was provided by the initial reporter: bi-tubing extension broke away from conjunction site.
Additional Manufacturer Narrative
A complaint of tubing separating at the conjunction site was received from the customer.A photo was provided for investigation.Separation is seen at the part where the set splits into two separate tubing lines.The customer complaint was confirmed.A device history record review for model mz9265 lot number 21105858 was performed.The search showed that a total of 7,203 units in 1 lot number were built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as a physical sample was not received.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15506356
• Report Number: 9616066-2022-01444
• Device Sequence Number: 20866408
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 10885403240775
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 09/16/2022

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: 10/23/2024
• Device Catalogue Number: MZ9265
• Device Lot Number: 21105858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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
• Patient Sex: Unknown