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

Catalog Number	MZX5305
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 during use with an unspecified amount of bd maxzero¿ pressure-rated extension set anesthesia would not flow.Device switched out and patient had multiple "pokes", there was no additional patient impact reported.The following information was provided by the initial reporter: anesthesia could not push fluid, thought iv was bad, wanted another iv started.I switched the iv fluid tubing to the secondary port and it flowed perfectly.Patients have been getting poked multiple times because we think the iv is bad, because it wont flush.But if we use the secondary port, fluid flows great.
Event or Problem Description
It was reported that during use with an unspecified amount of bd maxzero¿ pressure-rated extension set anesthesia would not flow.Device switched out and patient had multiple "pokes", there was no additional patient impact reported.The following information was provided by the initial reporter: anesthesia could not push fluid, thought iv was bad, wanted another iv started.I switched the iv fluid tubing to the secondary port and it flowed perfectly.Patients have been getting poked multiple times because we think the iv is bad, because it wont flush.But if we use the secondary port, fluid flows great.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 20-jun-2023.H6) investigation summary: one sample (model #mzx5305, lot #23029155) was returned by the customer.It was reported by the customer that anesthesia could not push fluid.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Each port of the set was connected to a 10 ml bd syringe and attempted to be flushed with water.Both ports of the set were able to be flushed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model mzx5305 lot number 23029155 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO¿ PRESSURE-RATED 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17132122
• Report Number: 9616066-2023-01187
• Device Sequence Number: 6487853
• Product Code: FPA
• UDI-Device Identifier: 10885403463785
• UDI-Public: (01)10885403463785
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K193088
• 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): 07/10/2023

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 Expiration Date: 02/09/2026
• Device Catalogue Number: MZX5305
• Device Lot Number: 23029155
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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