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

Catalog Number	MZ5309
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
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.No product or photo was returned by the customer.The customer complaint of loose component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mz5309 lot number 23059004 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.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.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
• Common Device Name: 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
• Report Number: 9616066-2024-00464
• Device Sequence Number: 17717042
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: (01)10885403242083
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: Health Professional
• Device Expiration Date: 05/02/2026
• Device Catalogue Number: MZ5309
• Device Lot Number: 23059004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown