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

Model Number	40000-07T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd alaris texium secondary set experienced leakage which lead to patient not receiving the entire dose of medication.The following information was provided by the initial reporter: chemotherapy dripping from between the male leur and the texium end.This resulted in a chemo spill and patient did not receive the entire dose of the medication - oxaliplatin.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-jun-2022.H6: investigation summary.The customer reported dripping between the texium and the male luer.The sample came with these two attached, and when the set was primed, there was no leakage.However, the connection was not normal.The texium was extremely tight in the luer, and they could not be separated.The texium was also not inserted fully into the male luer threads, it appeared to be threaded incorrectly.Perhaps the medication or other solution crusted around the connection and prevented further leakage.The complaint will be verified as connection issues.The sample was sent to the manufacturing site for further investigation and they found the root cause to be the torque fixture for the assembly of the connection.A quality alert was issued to the assembly personnel to address the issue.A device history record review for model 40000-07t lot number 22019006 was performed.
Event or Problem Description
It was reported that the bd alaris texium secondary set experienced leakage which lead to patient not receiving the entire dose of medication.The following information was provided by the initial reporter: chemotherapy dripping from between the male leur and the texium end.This resulted in a chemo spill and patient did not receive the entire dose of the medication - oxaliplatin.

• Brand Name: BD ALARIS TEXIUM SECONDARY SET
• 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: 14758548
• Report Number: 9616066-2022-00748
• Device Sequence Number: 6022863
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 01/03/2025
• Device Model Number: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: 22019006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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 Sex: Unknown