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

Catalog Number 2477-0007

Device Problem Backflow (1064)

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

Event Date 12/08/2023

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#: 23035095.It was reported by customer that blood iv administration line ran the blood into the ns bag despite the ns bag line being clamped.Verbatim#: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): 2023-12-08 type of incident/problem: defect (detected before use) level of harm: no apparent harm - reached patient/person, inconvenient ahs optional report to cmdsnet (health canada): yes incident details: blood iv administration line ran the blood into the ns bag despite the ns bag line being clamped.Who was affected? patient unexpected or prolonged care? no frequency of problem: recurring device information device name/description: set blood transfusion alaris pump non-vented 308cmx33ml 180 micron filter 15 drop with 1 smartsite valve manufacturer: carefusion manufacturer code/model: 2477-0007 serial or lot number: (b)(6).Expiry date: 2026-03-11 supplier: (b)(6).Supplier catalogue number: al2477-0007 is device retained: yes number of devices: 1 device handling hazards (when blank = hazards not specified): blood and/or body fluid contaminated wipe, contained, labeled? clean/not used.

• 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: 18608936
• MDR Text Key: 335088782
• Report Number: 9616066-2024-00130
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 2477-0007
• Device Lot Number: 23035095
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1