MAUDE Adverse Event Report: BECTON DICKINSON 40 IN EXT W/2 VLV PORTS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 37262E

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

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 #: unknown.Batch#: unknown.It was reported by customer that they experience leaking.Verbatim: rcc received a complaint via email.It has been brought to our attention that either, lawson # 133750 iv ext set w/2 nedl free sites ref# (b)(4) or lawson # 104516 needle iv autoguard 22g ref # (b)(4).Is leaking.They could not duplicate the issue with different items but are concerned.Just wanted you to be aware in case any other team members are reporting issues we are experience leaking with either item # 37262e or 382532 in the ed.Can you please help at (b)(6)?.

• Brand Name: 40 IN EXT W/2 VLV PORTS
• 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: 19198287
• MDR Text Key: 341808518
• Report Number: 9616066-2024-00643
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: (01)10885403235276
• 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: 37262E
• Device Lot Number: 24029188
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1