MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD 166-IN 15 DROP ADMIN/REMOVABLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX4436
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd 166-in 15 drop admin/removable iv tubing became disconnected.The following information was provided by the initial reporter: the iv tubing became disconnected at the stopcock.The opening allowed blood flow to come back up the tubing and onto the floor.This patient was also anticoagulated from their procedure so luckily it was caught relatively quickly as it could've caused significant bleeding.This opened up onto the floor and opened a possible source of infection for the patient.This is a frequent problem.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that iv tubing became disconnected at the stopcock could not be verified due to the product not being returned for failure investigation.A device history record review for model mx4436 lot number 24039161 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08mar2024.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.
Event or Problem Description
No additional info.

• Brand Name: BD 166-IN 15 DROP ADMIN/REMOVABLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: helen cox (mdr) ; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 19449032
• Report Number: 9616066-2024-00815
• Device Sequence Number: 3264556
• Product Code: FPA
• UDI-Device Identifier: 10885403237478
• UDI-Public: (01)10885403237478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Catalogue Number: MX4436
• Device Lot Number: 24039161
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown