MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD TEXIUM¿ NEEDLE-FREE SYRINGE; PISTON SYRINGE

Catalog Number	MY8030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that doxorubicin leaked from the bd texium¿ needle-free syringe during use.The following information was provided by the initial reporter: "the oncology technician has brought to my attention that the texium needle free syringe is experiencing some leaking/drug exposure when using.Recently, doxorubicin was used.And the drug can clearly be seen (since drug is red)".
Additional Manufacturer Narrative
H6: investigation summary: 3 photos as samples were received and tested by our quality team.The leak is clear enough in photos to verify this complaint.Without additional information like a physical sample for investigation, the root cause remains unknown.The manufacturer has been notified of this occurrence.A device history record review for model my8030 lot number 92126501 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that doxorubicin leaked from the bd texium¿ needle-free syringe during use.The following information was provided by the initial reporter: "the oncology technician has brought to my attention that the texium needle free syringe is experiencing some leaking/drug exposure when using.Recently, doxorubicin was used.And the drug can clearly be seen (since drug is red)".

• Brand Name: BD TEXIUM¿ NEEDLE-FREE SYRINGE
• Common Device Name: PISTON SYRINGE
• 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: 16018741
• Report Number: 9616066-2022-02017
• Device Sequence Number: 17866022
• Product Code: FMF
• UDI-Device Identifier: 10885403230523
• UDI-Public: 10885403230523
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• 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,Followup
• Report Date (Section B): 02/02/2023

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: Health Professional
• Device Expiration Date: 09/22/2024
• Device Catalogue Number: MY8030
• Device Lot Number: 92126501
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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