MAUDE Adverse Event Report: BECTON DICKINSON PRESSURE RATED EXTENSION SET, IV CONNECT; INTRAVENOUS EXTENSION TUBING SET

Catalog Number MZ5309

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

Material # mz5309 lot # 23059004 it was reported by customer that j loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.Verbatim: rcc received a complaint via email.Email(s) attached.J loop malfunctioned.It was pouring out normal saline as nurse was pushing it.Connections were checked and they were tightened.No harm came to patient.Product#: mz5309 lot#: 23059004.

• Brand Name: PRESSURE RATED EXTENSION SET, IV CONNECT
• Type of Device: INTRAVENOUS EXTENSION TUBING SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 18969400
• MDR Text Key: 338498621
• Report Number: 9616066-2024-00464
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: (01)10885403242083
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ5309
• Device Lot Number: 23059004
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1