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

Catalog Number 11522558

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2024

Event Type  malfunction  

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 Description

Material#: 11522558.Batch number#: 22095036.It was reported by customer that issue has been reported regarding potential leaking.Verbatim#: rcc received a complaint via email.Our customer has lodged a complaint regarding item#: 11522558, lot#: 22095036.The complaint is as follows: please note that an issue has been reported regarding potential leaking of l 135161, c # (b)(4) iv set pump w/ball 3 port with lot number (10) 22095036.Value analysis has requested this item and lot number be pulled from use and returned to concordance for return to the manufacturer.Please provide rga for the return of 601 ea of this item.

• Brand Name: AS LVP 20D 3SS CV BV
• Type of Device: 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: 19199069
• MDR Text Key: 342002475
• Report Number: 9616066-2024-00652
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: (01)10885403232305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 11522558
• Device Lot Number: 22095036
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1