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

Catalog Number	MZX5305
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd maxzero¿ extension set experienced component separation.The following information was provided by the initial reporter: set is disconnected at juncture.
Event or Problem Description
It was reported that the bd maxzero¿ extension set experienced component separation.The following information was provided by the initial reporter: set is disconnected at juncture.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of set disconnected at juncture could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mzx5305 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.

• Brand Name: BD MAXZERO¿ EXTENSION SET
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16550448
• Report Number: 9616066-2023-00457
• Device Sequence Number: 20344365
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 04/07/2023

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 Catalogue Number: MZX5305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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