MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SECONDARY IV ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Model Number	11582774
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: patient¿s birthday was not provided, 01-jan-2015 was used based on age of patient.Investigation summary: one sample was received for quality investigation.The customer complaint of component damage - no leak was verified by visual inspection.Evaluation of the sample received indicates that the male luer spin collar separated from the body of the male luer connector.Further evaluation under magnification shows that the male luer spin collar is cracked and therefore making it easy to separate from the male luer connector body.A device history record review for model: 11582774 lot number :22039298 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 22mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the damage seen on the sample could not be fully determined based on the events described by the customer and the investigation of the sample.The probable root cause for the issue seen in this complaint is that the male luer connector was tighten too tight causing the spin collar to crack.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 secondary iv administration sets experienced damage product.The following information was provided by the initial reporter: i disconnected one of the secondary sets from the primary and when i went to put a green cap on the end of the secondary, the connection port of the secondary broke completely away from the tubing.There was no harm to the patient because this occurred while detaching a completed secondary.

• Brand Name: BD SECONDARY IV ADMINISTRATION SETS
• 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: 15033016
• Report Number: 9616066-2022-00890
• Device Sequence Number: 15189356
• Product Code: FPA
• UDI-Device Identifier: 50885403234758
• UDI-Public: 50885403234758
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 06/17/2022

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: 03/22/2025
• Device Model Number: 11582774
• Device Catalogue Number: 11582774
• Device Lot Number: 22039298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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 Age: 7 YR
• Patient Sex: Male