MAUDE Adverse Event Report: BECTON DICKINSON AS LVP 20D LOW SORB; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2260-0500
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 2260-0500.Lot # 24025014.It was reported by customer that the male luer was missing and it caused 15 ml of hydromorfone medication to waste.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint.Product #2260-0500.Lot # 24025014.Description: defective item, the male luer was missing and it caused 15 ml of hydromorfone medication to waste.No patient or hcp impact known to reporter.Physical sample is available.Facility: (b)(6) hospital.Address: (b)(6).
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.
Additional Manufacturer Narrative
It was reported by customer that the male luer was missing and it caused 15 ml of hydromorphone medication to waste.No product or photo was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 2260-0500 lot number 24025014 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01feb2024.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.
Event or Problem Description
No additional information was provided.

• Brand Name: AS LVP 20D LOW SORB
• 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: 19199083
• Report Number: 9616066-2024-00659
• Device Sequence Number: 7620533
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: (01)07613203012591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/08/2024

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: 2260-0500
• Device Lot Number: 24025014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 04/28/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown