MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD EXTENSION SET 2-WAY MAXZERO¿; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5316
Medical Device Problem Codes	Defective Component (2292); Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
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 during use with bd extension set 2-way maxzero¿ the device was misassembled.The following information was provided by the initial reporter: iv saline lock has three ports instead of two ports and a place to attach the saline lock to the iv hub.
Event or Problem Description
It was reported that during use with bd extension set 2-way maxzero¿ the device was misassembled.The following information was provided by the initial reporter: iv saline lock has three ports instead of two ports and a place to attach the saline lock to the iv hub.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of set having three ports instead of two was received from the customer.A photo was provided by the customer where the set is seen misassembled.An extra maxzero is assembled in place of the male luer.A device history record review for model mz5316 lot number 23019331 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 23jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The probable root cause for this defect is an error during the assembly process.The manufacturing plant was notified of this defect, and an investigation was completed.After investigation, the possible root cause for misassembly was related to not correctly following the assembly procedure.As a containment action, a quality alert was created and communicated to production personnel to inform this failure mode and reinforce the operations described in the procedure to carry out a correct assembly (components described in the operations flow).

• Brand Name: BD EXTENSION SET 2-WAY MAXZERO¿
• 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: 17276285
• Report Number: 9616066-2023-01366
• Device Sequence Number: 3584876
• Product Code: FPA
• UDI-Device Identifier: 10885403471278
• UDI-Public: (01)10885403471278
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: Health Professional
• Device Expiration Date: 01/23/2026
• Device Catalogue Number: MZ5316
• Device Lot Number: 23019331
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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