MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 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	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Fda notified: the initial reporter notified the fda via mdr report #: 13450848.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 2 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: filter found to be leaking.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 09-mar-2022.Investigation: the set leaked from the filter air vent, and the complaint is verified.Further investigation was done by shipping the sample to the supplier of the filter.The supplier performed a visual inspection where no evidence of damage to the vent membrane was found; additionally, the membrane was intact and a complete welding seal around the parts was observed.During the functional inspection, the supplier verified the leak; however, the filter's functionality was restored by flushing with distilled water for several hours and leaving to dry.Since the filter was able to be 'washed' and did not leak after its restoration, the root cause is attributed to the drugs/solutions being used in the filter.The investigation results suggest that the filter¿s membrane was clogged and the hydrophobicity of the membrane was compromised at the time of the leak.The filter clogged because it was doing its job and collecting particulates.A device history record review could not be performed on model mz9273 because the lot number is unknown.
Event or Problem Description
It was reported that 2 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: filter found to be leaking.

• Brand Name: BD 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: 13773510
• Report Number: 9616066-2022-00237
• Device Sequence Number: 17401580
• 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): 05/26/2022

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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 06/13/2022
• 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