MAUDE Adverse Event Report: BECTON DICKINSON AS LVP BLD180M 15D SS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2477-0007

Device Problem Break (1069)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (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#: 2477-0007, batch number#: 23095050.It was reported by customer that they feel clamp the clamp it is damaging the tubing causing cracks and leaks.When he used the spike the blood from the bag was leaking around the spike and is 100% sure that the bag was not poked or damaged at all.All tubing used in the 3 incidents were in date and no damage to the package.Verbatim#: rcc received a complaint via email.Email(s) attached.Nurse stated that they feel clamp the clamp it is damaging the tubing causing cracks and leaks.When he used the spike the blood from the bag was leaking around the spike and is 100% sure that the bag was not poked or damaged at all.All tubing used in the 3 incidents were in date and no damage to the package.Item#2477-0007, lot#23095050.

Manufacturer Narrative

Dhr: no product or photo was returned by the customer.The customer complaint of the clamp it is damaging the tubing causing cracks and leaks, and also leaking around the drip chamber/spike could not be verified due to the product not being returned for failure investigation.Device history record review for model 2477-0007, lot number 23095050 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 08sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information was provided.

• Brand Name: AS LVP BLD180M 15D SS
• Type of Device: 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: 18608661
• MDR Text Key: 335089759
• Report Number: 9616066-2024-00129
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2477-0007
• Device Lot Number: 23095050
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1