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

Catalog Number	10015414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr with device evaluation.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.The affected product's lot number could not be confirmed by the customer.However, the customer suspects that the lot number could be 24045458.A device history record review for material# 10015414 and lot# 24045458 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23apr2024.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.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 or Problem Description
Material: 10015414.Batch#: unknown.It was reported by the customer that noted blood on iv pole and throughout interior of the pump channel after transfusion.No notable hole but possibly coming from just below the blue hard plastic piece where the tubing is fed into the channel.Verbatim: rcc received a complaint via email.Email(s) attached.Reporter noted blood on iv pole and throughout interior of the pump channel after transfusion.No notable hole but possibly coming from just below the blue hard plastic piece where the tubing is fed into the channel.Pump did not alarm with a problem throughout the whole 2 hour transfusion.

• Brand Name: AS LVP BLD180M 15D DEHP
• 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: 20858155
• Report Number: 9616066-2024-01885
• Device Sequence Number: 3864906
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: (01)10885403233999
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10015414
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown