MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE¿ TRI-FUSE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ9266

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported by customer that missing the cap and cut off in one of the lines.Report 1 of 2.The following was received by the intial customer: its missing the cap and cut off in one of the lines.

Manufacturer Narrative

H.6 investigation summary: a complaint of a cap missing and tubing being cut off was received from the customer.A photo was provided by the customer for investigation.It was observed that a maxzero is missing from the set inside the packaging.It is also noted that the blue slide clamp is inside the packaging, but the third piece of tubing was missing.A device history record review for model mz9266 lot number 23019245 was performed.The search showed that a total of (b)(4)units in 1 lot number were built on 15jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being received, a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD MICROBORE¿ TRI-FUSE EXTENSION SET
• Type of Device: 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17568522
• MDR Text Key: 321823851
• Report Number: 9616066-2023-01755
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403240789
• UDI-Public: (01)20885403240789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: MZ9266
• Device Lot Number: 23019245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1