MAUDE Adverse Event Report: BECTON DICKINSON AS LVP BLD200M 20D DEHP SMBORE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2278-0500
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material # 2278-0500; batch # 24075304.It was reported by customer that blood tubing used for blood administration sprung a leak in the portion of the tubing that is softer that sits inside of the iv pump channel.While getting the transfusion set up, reporter went to close the channel and noticed some blood dripping down the tubing.Reporter opened channel back up and took tubing out of the channel and blood squirted out of a small hole in the tubing.Rcc received a complaint via email.Blood tubing used for blood administration sprung a leak in the portion of the tubing that is softer that sits inside of the iv pump channel.While getting the transfusion set up, reporter went to close the channel and noticed some blood dripping down the tubing.Reporter opened channel back up and took tubing out of the channel and blood squirted out of a small hole in the tubing.Lot: 24075304.
Additional Manufacturer Narrative
It was reported by customer that blood tubing used for blood administration sprung a leak in the portion of the tubing that is softer that sits inside of the iv pump channel.One sample was received for quality evaluation.Visual inspection was conducted and there were no damages or abnormalities identified.The infusion set was then primed a leak was found on the silicone tubing near the upper pumping segment fitting.Further inspection, under magnification, shows that there is a hold in the silicone tubing.The customer complaint of tubing defective / damaged was confirmed.Based on the description of the failure and investigation of the submitted sample, the root cause of the failure was determined to be a misloading of the infusion set.The failure was noticed when the pump door was closed, and once the pump door was opened the blood started squirting out.There was no indication of a leak during priming of the infusion set and therefore the failure would have been created during the loading of the set to the pump.A device history record review for model 2278-0500 lot number 24075304 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material # 2278-0500 batch # 24075304.It was reported by customer that blood tubing used for blood administration sprung a leak in the portion of the tubing that is softer that sits inside of the iv pump channel.While getting the transfusion set up, reporter went to close the channel and noticed some blood dripping down the tubing.Reporter opened channel back up and took tubing out of the channel and blood squirted out of a small hole in the tubing.Rcc received a complaint via email.Blood tubing used for blood administration sprung a leak in the portion of the tubing that is softer that sits inside of the iv pump channel.While getting the transfusion set up, reporter went to close the channel and noticed some blood dripping down the tubing.Reporter opened channel back up and took tubing out of the channel and blood squirted out of a small hole in the tubing.Lot -24075304.

• Brand Name: AS LVP BLD200M 20D DEHP SMBORE
• 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: 20857780
• Report Number: 9616066-2024-01884
• Device Sequence Number: 8730031
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: (01)10885403223266(11)240726(17)270726(10)24075304
• 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,Followup
• Report Date (Section B): 01/31/2025

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: 2278-0500
• Device Lot Number: 24075304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown