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

Model Number	MZ9326
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd maxzero¿ extension set, minibore, trifuse the product was damaged.There was no report of patient impact.The following information was provided by the initial reporter: mz9326 lot# 22119144 verbatim:describe the event or problem: bd max zero trifuse with missing luer lock connector on third end and line appearing as though it was cut, package intact.
Additional Manufacturer Narrative
D.4.Medical device lot #: 22119144 was reported, however, this is not a lot # manufactured for the reported catalog #.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9266 lot number 22119144 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported while using bd maxzero¿ extension set, minibore, trifuse the product was damaged.There was no report of patient impact.The following information was provided by the initial reporter: mz9326 lot# 22119144 verbatim:describe the event or problem: bd max zero trifuse with missing luer lock connector on third end and line appearing as though it was cut, package intact.

• Brand Name: BD MAXZERO¿ EXTENSION SET, MINIBORE, TRIFUSE
• 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 ; 8448235433
• MDR Report Key: 16987763
• Report Number: 9616066-2023-00993
• Device Sequence Number: 15144293
• Product Code: FPA
• UDI-Device Identifier: 50885403427259
• UDI-Public: (01)50885403427259
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/31/2023

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 Model Number: MZ9326
• Device Catalogue Number: MZ9326
• Device Lot Number: 22119144
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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