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

Catalog Number	24010-0007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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.A device history record review could not be performed on material 24010-0007t because the lot number is unknown.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
Materials: 24010-0007t; batch#: unknown.It was reported by the customer that there have been several events involving bd texium tubing and syringes where nurses and patients have been at risk for exposure to hazardous drug due to leaking products.Verbatim: rcc received a complaint via email.Email(s) attached.There have been several events involving bd texium tubing and syringes where nurses and patients have been at risk for exposure to hazardous drug due to leaking products.We have been in contact with bd but have not yet found a resolution to this issue.Model #: 24010-0007t.(b)(6) 2024 (b)(6) - 24010-0007t lot / exp not available - during doxorubicin.Infusion, the y-site where the syringe is connected to the primary tubing was leaking when the medication was administered.2 out of 3 syringes leaked at the y-site.May involve my8020/my8030 syringes.

• Brand Name: AS LVP 20D 3SS TEX 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: 20864000
• Report Number: 9616066-2024-01897
• Device Sequence Number: 8592183
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: (01)10885403271021
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 24010-0007T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/06/2024
• 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