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	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.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: leaking filter of trifuse set.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-feb-2022.H6: investigation summary the customer reported the filters were leaking, and returned four used samples of material mz9273, and 1 single fuse short extension filter mz set.All 4 of the mz9273 sets leaked from the filter and 3 of the 4 were occluded with medication when returned.The remaining single fuse set did not leak, but had residue of a white opaque liquid.The filters were sent to the supplier for further investigation to find the root cause for the leaking.The supplier investigation found that the hydrophobicity of the membranes were compromised, and failed even after the first step of flushing the filter for 48 hours.The next step was to clean with alcohol and cotton swabs, and then cook in an oven to dry out any solutions.After this, they were able to restore them to a normal, non-leaking state.The conclusion is the drugs/solution used by the end user falls under the membrane supplier recommended surface tension of 30 dynes/cm.The solutions used with the membrane may also 'wet out' from 30 - 40 dynes/cm depending on duration and pressure.Alcohol in the drug is often the main culprit for falling under the surface tension specifications.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 the bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: leaking filter of trifuse set.

• 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: 13497848
• Report Number: 9616066-2022-00095
• Device Sequence Number: 4113967
• 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): 03/11/2022

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: 01/27/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/08/2022
• 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