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

Catalog Number	MZ5316
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero ext set was broke.The following information was received by the initial reporter with the verbatim: rn placed iv in a new admission labor patient, when she placed the extension on the iv catheter in patients' arm, blood immediately started coming out of the end of the site.Upon further investigation, the nurse realized that the end of the y-site had broken off.She clamped the line and proceeded to change out the y-site for another.The product and its' wrapper were kept for investigation afterwards.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by the customer that when rn placed the extension on the iv catheter in patient's arm, blood immediately started coming out of the end of the site.Upon further investigation by the nurse, the nurse realized that the end of the y-site had broken off.No product or photo was returned by the customer.The customer complaint of component damage - 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 mz5316 lot number 23039122 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03mar2023.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.Material #: mz5316 batch #: 23039122 it was reported by the customer that when rn placed the extension on the iv catheter in patient's arm, blood immediately started coming out of the end of the site.Upon further investigation, the nurse realized that the end of the y-site had broken off.Verbatim: ref.# (b)(4).Rn placed iv in a new admission labor patient, when she placed the extension on the iv catheter in patient's arm, blood immediately started coming out of the end of the site.Upon further investigation, the nurse realized that the end of the y-site had broken off.She clamped the line and proceeded to change out the y-site for another.The product and it's wrapper were kept for investigation afterwards.Catalog # mz5316 lot / serial # (b)(6).

• Brand Name: BD MAXZERO EXT 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: 17996429
• Report Number: 9616066-2023-02129
• Device Sequence Number: 14923791
• Product Code: FPA
• UDI-Device Identifier: 10885403471278
• UDI-Public: (01)10885403471278
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/04/2023

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 Expiration Date: 05/20/2025
• Device Catalogue Number: MZ5316
• Device Lot Number: 23039122
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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