MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5307
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd maxzero multi-fuse pressure rated extension set with needleless connector(s) the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: i just happened to find this defective bifuse.
Additional Manufacturer Narrative
H6: investigation summary one sample of material number mz5307 was received for quality investigation.The customer complaint of component damage - no leak was verified by visual inspection.Evaluation of the sample showed that the extension set was packaged and sealed without the luer connection attached.A device history record review for model mz5307 lot number 22089189 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13aug2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure is that the connection luer was not attached and packaged at the manufacturing facility.The investigation had been forwarded to the manufacturer for further investigation.Investigation of the packaging at the manufacturing facility identified an opening in the packaging seal.The unsealed location in the addition to the missing end connection leads us to believe that the tubing was outside of the packaging area at the time of sealing.This caused damage in the tubing along with not completely sealing the package.A quality alert was generated to prevent the issue in future product production.
Event or Problem Description
It was reported while using bd maxzero multi-fuse pressure rated extension set with needleless connector(s) the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: i just happened to find this defective bifuse.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16209718
• Report Number: 9616066-2023-00029
• Device Sequence Number: 4341262
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 08/13/2025
• Device Catalogue Number: MZ5307
• Device Lot Number: 22089189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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