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	MZ9267
Medical Device Problem Codes	Complete Blockage (1094); Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
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 2 bd maxzero¿ multi-fuse extension sets with needleless connector were blocked while attempting to prime the tubing.The following information was provided by the initial reporter: "we are having issues with part number 20029e, the micron filter is leaking and this a huge safety concern because a critical med was leaking.This has been happening about 3-4 times now in the past week or so.Are you able to provide event date? nicu: i believe the nurse wrote the date on the products that would not flush.Can you identify the batch number? lot # 23059265.Is there any adverse event occurred? nicu: no.As reported, there was a safety issue happened, can you provide details? nicu: nurse reported that she was not able to prime two tubings.".
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by customer that they are having additional issues that nurse reported was not able to prime two tubing with lot number 23059265 could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9267 and lot number 23059265 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.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.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 bd maxzero¿ multi-fuse extension sets with needleless connector were blocked while attempting to prime the tubing.The following information was provided by the initial reporter: "we are having issues with part number 20029e, the micron filter is leaking and this a huge safety concern because a critical med was leaking.This has been happening about 3-4 times now in the past week or so.- are you able to provide event date? nicu: i believe the nurse wrote the date on the products that would not flush.- can you identify the batch number? lot # 23059265 - is there any adverse event occurred? nicu: no - as reported, there was a safety issue happened, can you provide details? nicu: nurse reported that she was not able to prime two tubings.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17515925
• Report Number: 9616066-2023-01730
• Device Sequence Number: 17544798
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: 10885403240720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/16/2023

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: 05/19/2026
• Device Catalogue Number: MZ9267
• Device Lot Number: 23059265
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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