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

Model Number	MZ9273
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown fda notified: the initial reporter also notified the fda via medwatch uf/importer report #: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: ivf leaking at tpn filter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 11-jul-2022.H6: investigation summary: samples were received and tested by our quality team.The sets presented with leaks in filters just like the customer described- this verified the complaint.The cause for these leaks is unknown but our manufacturing and r&d teams are aware of this and diligently working to solve the issue of filter leaks.The sets and filters were then sent to the filter manufacturer in italy where they were washed to remove any biological material or substance left from clinical use.Once the filters and their respective membranes were cleaned completely, the supplier reported no leakage or issues with the sets whatsoever.The filters were tested using pressurized infusion and forced leaks were only noticed at pressures high above any that would be used in clinical setting.Visual analyses under microscope also confirmed that there were no abnormalities in any of these filters or sets.This failure remains an unknown root cause but our engineers and researchers are working diligently to eliminate reoccurrence.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: ivf leaking at tpn filter.

• Brand Name: MAXZERO MULTI-FUSE 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: 13670490
• Report Number: 9616066-2022-00202
• Device Sequence Number: 5466573
• Product Code: FPA
• UDI-Device Identifier: 50885403240858
• UDI-Public: 50885403240858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/22/2022

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 Model Number: MZ9273
• Device Catalogue Number: MZ9273
• Device Lot Number: UNKNOWN
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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