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

Catalog Number	MZ9277
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 separated the following information was received by the initial reporter with the following verbatim: date of delivery of the product: product description: a 10 year old child patient had a maxzero extension tube at the end of a cannula pulled across the end of the cannula.The blue part of the valve plug came off.A similar situation has occurred once before in the paediatric ward.We have also tried the extension hose ourselves and the blue end comes off with a firm pull.Is this a feature or a deterioration in quality? it does not seem a safe product in the children's department.
Additional Manufacturer Narrative
Additional information: details added to b5 from customer.Based on this info, e and f codes updated since initial submission.Investigation results: three mz9277 samples were received in sealed packaging from lot 22049314 for investigation.The customer reported that "maxzero valve has detached from the end of extension".The returned samples were sent to the bd product test laboratory (ptl) and subjected to tensile strength testing in accordance with the requirements of bs: en: iso 8536-9: "infusion equipment for medical use.Fluid lines for use with pressure infusion equipment".The product met and exceeded the tensile requirements of the standard and no separation between the tubing and filter joint occurred.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.A review of the production records for lot 22049314 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definite root cause for this issue, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz9277 set in the past 12 months.
Event or Problem Description
Additional information from the customer: please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? during use, during infusion.Please confirm the exact location of the reported fault within the set? the valve has detached from the extension tubing.Was there any leakage observed? yes, the extension was leaking afterwards the valve was detached.Was there any patient harm? no.

• Brand Name: BD MAXZERO
• 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: 19300858
• Report Number: 9616066-2024-00715
• Device Sequence Number: 12483234
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: (01)10885403240799
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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: 04/25/2025
• Device Catalogue Number: MZ9277
• Device Lot Number: 22049314
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown