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	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero extension set was damaged the following information was received by the initial reporter with the following verbatim: ¿connected extension tubing to iv catheter, connected to iv fluids and the extension tubing came part from itself.Iv fluids were flowing out, luckily no blood leak from extension part that was still attached to pt and iv.Fluids disconnected and new extension tubing connected¿ 1.Are you able to provide the date of event in format dd-mmm-yyyy? 18-04-2024.2.Are you able to provide the batch/lot number? unknown.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? n/a.7.Was there any delay of, or change in, the course of treatment due to this event? yes, need to obtain new products and setup.8.What procedure was being performed? administration of iv fluids.9.What medication was used in the procedure? n/a.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.Yes!.
Additional Manufacturer Narrative
It was reported that the sample separated.One sample model mzx5305, lot 24029231 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the inlet of the y-site.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause is the insufficient solvent applied to the tubing by the assembler.A quality alert was created on may 14th, 2024 to communicate the failure and reinforce the correct solvent application method and avoid the separation due to lack of solvent.A device history record review for model mzx5305 lot number 24029231 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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional info.

• 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: 19310921
• Report Number: 9616066-2024-00736
• Device Sequence Number: 17846577
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/19/2024

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: 24029231
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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