MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D DEHP 3SS 15M CV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10561554
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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: 10561554 batch#: unknown it was reported by the customer that tubing broke off at the end of the infusion while it was flushing.No patient harm.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Follow up mdr for device evaluation.The customer reported tubing broke off, and returned one used sample of material 10561554, lot 23105399.Upon initial visual examination, the set confirmed the failure and was separated at the lower fitment, press ring-retainer fitment.The ring retainer was found to have been attached to the silicon pump segment, when the silicon segment was examined under a microscope.In addition, the little blue ring retainer was seen in the customer photos.The root cause was not able to be attributed to the manufacturing assembly process.A potential root cause is clinical practice, and our clinical team has been notified.Device history record review for model 10561554 lot number 23105399 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19oct2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: AS LVP 20D DEHP 3SS 15M CV
• 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: 20877854
• Report Number: 9616066-2024-01938
• Device Sequence Number: 7804809
• Product Code: FPA
• UDI-Device Identifier: 10885403232565
• UDI-Public: (01)10885403232565
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 10561554
• Device Lot Number: 23105399
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown