MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4450
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using a bd 64" (163 cm) stdbore ext set w/two 4-way the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: in addition, another defective tubing was identified but not reported with a patient event.The defective tubing was dropped off in my office on (b)(6) 2022.It is the same lot number ending in x30.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using a bd 64" (163 cm) stdbore ext set w/two 4-way the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: in addition, another defective tubing was identified but not reported with a patient event.The defective tubing was dropped off in my office on 9/9/2022.It is the same lot number ending in x30.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of defective tubing was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing defective/ damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model mx4450 lot number 22049030 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY
• 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: 15481558
• Report Number: 9616066-2022-01416
• Device Sequence Number: 12500669
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 02/07/2023

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: Other
• Device Catalogue Number: MX4450
• Device Lot Number: 22049030
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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