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

Catalog Number	MZ9283
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6) medical center h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set broke the following information was received by the initial reporter with the following verbatim: over the last 2 months we have experienced issues with two products.First, on one patient the medication tubing (mz9267) luer lock device fall off the tubing.It looks like the device was not fused well to the tubing.Second, the luer hub that twists on the quadfuse (mz9283) broke into multiple pieces while in use on a patient.I am not sure if a hemostat was used to loosen the luer or if it was damaged during transit.
Additional Manufacturer Narrative
The customer reported that the sample broke off.One sample model mz9283 was returned for investigation.The set was examined for defects and abnormalities.The set was missing the spinning male lock.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the supplier.From the supplier's investigation, the cause could not be determined.It is possible that post-manufacturing mishandling could have caused this.Without a valid lot number, no manufacturing records review could be performed.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional info.

• Brand Name: BD MAXZERO MULTI-FUSE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18536077
• Report Number: 9616066-2024-00029
• Device Sequence Number: 6545187
• Product Code: FPA
• UDI-Device Identifier: 10885403230660
• UDI-Public: (01)10885403230660
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Catalogue Number: MZ9283
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown