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

Catalog Number	MZ5316
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 needleless connector separated the following information was received by the initial reporter with the following : "the extension set snapped at the junction where the extension set bifurcates without any force or pulling at all.It just came apart and all of her iv fluid poured out." customer does not have the sample available to turn in, but has photos - see attached.She also didn't save the product label and does not have the lot number, she said the two lot numbers that are in their stock are lot#23039122 and lot#23099202.
Additional Manufacturer Narrative
The customer reported the set came apart at the junction, and returned photos of the incident.The photos were examined, and the separation was verified.The set issue was confirmed at the outlet of smart site at the y-site.Without the physical sample, there was no way to investigate the tubing itself.The investigation was unable to attribute a root cause without the physical samples, but the complaint was confirmed.Device history record review for model mz5316 lot number 23039122 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06mar2023.Device history record review for model mz5316 lot number 23099202 was performed.The search showed that a total of 6,003 units in 1 lot number was built on 25sep2023.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 information was provided.

• Brand Name: BD MAXZERO NEEDLELESS CONNECTOR
• 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: 18779158
• Report Number: 9616066-2024-00302
• Device Sequence Number: 20875470
• Product Code: FPA
• UDI-Device Identifier: 10885403471278
• UDI-Public: (01)10885403471278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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 Expiration Date: 09/10/2026
• Device Catalogue Number: MZ5316
• Device Lot Number: 23099202
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown