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

Catalog Number	MZ9277
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified number of bd maxzero¿ multi-fuse extension set with needleless connectors had flow issues while injecting radioactive tracers, as well as during the flushing process.The following information was provided by the initial reporter: "the maxzero extension tubing creates back splash when injecting radioactive tracers.This causes significant contamination to he patient and unnecessary exposure to the caregiver staff and nursing teams on the floor.In addition to the contamination, the tracer, even when flushed, collects in the maxzero blue hub which reduces the image quality of our cardiac stress patients and potentially exposes nursing teams on the floor.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported by the customer that the maxzero extension tubing creates back splash when injecting radioactive tracers could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mz9277 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that an unspecified number of bd maxzero¿ multi-fuse extension set with needleless connectors had flow issues while injecting radioactive tracers, as well as during the flushing process.The following information was provided by the initial reporter: "the maxzero extension tubing creates back splash when injecting radioactive tracers.This causes significant contamination to he patient and unnecessary exposure to the caregiver staff and nursing teams on the floor.In addition to the contamination, the tracer, even when flushed, collects in the maxzero blue hub which reduces the image quality of our cardiac stress patients and potentially exposes nursing teams on the floor.".

• Brand Name: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 15795126
• Report Number: 9616066-2022-01730
• Device Sequence Number: 14650327
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: (01)10885403240799
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/09/2022

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: Health Professional
• Device Catalogue Number: MZ9277
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/20/2022
• 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