MAUDE Adverse Event Report: BECTON DICKINSON 40 IN STANDARDBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX4439
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # mx4439; batch # 24069065.It was reported by customer that stop-cock with propofol in lumen but locked and connected to patient as lactated ringer's gravity infusion number of drops (gtt).Locked the gtt with roller clamp and distal clamp near iv.Removed the stopcock and noticed that the plastic luer-lock inside the lumen sheared off.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material # mx4439.Batch # 24069065.It was reported by customer that stop-cock with propofol in lumen but locked and connected to patient as lactated ringer's gravity infusion number of drops (gtt).Locked the gtt with roller clamp and distal clamp near iv.Removed the stopcock and noticed that the plastic luer-lock inside the lumen sheared off.Verbatim: rcc received a complaint via email.Stop-cock with propofol in lumen but locked and connected to patient as lactated ringer's gravity infusion number of drops (gtt).Locked the gtt with roller clamp and distal clamp near iv.Removed the stopcock and noticed that the plastic luer-lock inside the lumen sheared off.Product number - mx4439.Lot number - 24069065.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# mx4439 and lot# 24069065 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04jun2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: 40 IN STANDARDBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20878102
• Report Number: 9616066-2024-01940
• Device Sequence Number: 7804820
• Product Code: FPA
• UDI-Device Identifier: 10885403237485
• UDI-Public: (01)10885403237485(11)240604(17)290603(10)24069065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 01/09/2025

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 Catalogue Number: MX4439
• Device Lot Number: 24069065
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White