MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP BLD180M 15D DEHP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015414
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ lvp bld180m 15d dehp experienced component separation, and leakage.The following information was provided by the initial reporter: there was a tubing separation at the drip chamber with blood tubing.It was noted to be dripping but not ¿completely separated." the iv set was changed out.This is the first time it has occurred with blood tubing.No patient harm.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of drip chamber separation could not be verified due to the product not being returned for failure investigation.Device history record review for model 10015414 lot number 22066316 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported that the bd alaris¿ lvp bld180m 15d dehp experienced component separation, and leakage.The following information was provided by the initial reporter: there was a tubing separation at the drip chamber with blood tubing.It was noted to be dripping but not ¿completely separated¿.The iv set was changed out.This is the first time it has occurred with blood tubing.No patient harm.

• Brand Name: BD ALARIS¿ LVP BLD180M 15D DEHP
• 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: 16099611
• Report Number: 9616066-2022-02128
• Device Sequence Number: 20391759
• Product Code: FPA
• UDI-Device Identifier: 50885403233997
• UDI-Public: 50885403233997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• 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): 01/31/2023

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: 06/27/2025
• Device Model Number: 10015414
• Device Catalogue Number: 10015414
• Device Lot Number: 22066316
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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