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	MZ9275
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Bacteremia (4846)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unspecified number of bd maxzero¿ multi-fuse extension sets with needleless connector had issues with the hub cracking and breaking off.As a result, the patient developed clabsi shortly after, but no further information on the treatment was provided.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "now we are having an issue with the quad lumen extension set (cat # mz9275).Yes, they are all on patients and have had it happen after being on for only for a shift.Can you please describe the issue? the hub cracked and broke off.Are there any adverse event or serious injuries reported on patient or health professional? clabsi reported shortly after this patient around the same time as discovered the crack.What type of procedure was being performed? n/a.What was the medication being used? iv fluids and vasopressin.Was there a delay of, or change in, the course of treatment due to the event? yes unsure of what.Was there any exposure to blood/bodily fluid/iv solution? yes".
Event or Problem Description
It was reported that an unspecified number of bd maxzero¿ multi-fuse extension sets with needleless connector had issues with the hub cracking and breaking off.As a result, the patient developed clabsi shortly after, but no further information on the treatment was provided.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "now we are having an issue with the quad lumen extension set (cat # mz9275).Yes, they are all on patients and have had it happen after being on for only for a shift.Can you please describe the issue? the hub cracked and broke off.Are there any adverse event or serious injuries reported on patient or health professional? clabsi reported shortly after this patient around the same time as discovered the crack what type of procedure was being performed? n/a.What was the medication being used? iv fluids and vasopressin.Was there a delay of, or change in, the course of treatment due to the event? yes unsure of what.Was there any exposure to blood/bodily fluid/iv solution? yes".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-jun-2023.H6: investigation summary sample was returned and the complaint is verified.The quadfuses had cracked and broken male luers.The root cause could not be found.In the past, overuse of alcohol wipes has been a culprit for the luers breaking.A device history record review could not be performed on material mz9275 because the lot number is unknown.H3 other text : see h10.

• 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 ; 8448235433
• MDR Report Key: 16931950
• Report Number: 9616066-2023-00899
• Device Sequence Number: 7033223
• Product Code: FPA
• UDI-Device Identifier: 10885403240768
• UDI-Public: 10885403240768
• 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): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MZ9275
• Device Lot Number: UNKNOWN
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown