MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZX5305
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bd maxzero extension set separated the following information was received by the initial reporter with the following verbatim: bd max zero extension iv set.Blue end of set came apart after hooked up to patient, blood then flowed freely onto the patient and floor.1.Are you able to provide the date of event in format dd-mmm-yyyy? (b)(6) 2024 2.Are you able to provide the batch/lot number? 24029233 3.Was issue being described noted before, or during used? during use 4.Was there any patient involvement? yes 5.Any adverse events or serious injury reported to patient or healthcare professional? no 6.What was the patient outcome? unknown 7.Was there any delay of, or change in, the course of treatment due to this event? no 8.What procedure was being performed? iv access and management 9.What medication was used in the procedure? unknown 10.Was there any medical intervention due to this event? no 11.Does a return shipping label need to be generated? if yes, kindly provide the sender¿s name and address.Unsure at this time.If so, please send to address below (b)(6) center xxxxxxxxxxxxx xxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxx.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that the bd max zero extension iv set.Blue end of set came apart after hooked up to patient, blood then flowed freely onto the patient and floor.No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mzx5303 lot number 24029233 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09feb2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MAXZERO EXTENSION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19356498
• Report Number: 9616066-2024-00768
• Device Sequence Number: 12354309
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: Other
• Device Catalogue Number: MZX5305
• Device Lot Number: 24029233
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown