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

Catalog Number	37262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by customer that they experience leaking.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.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 37262e lot number 24029188 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07feb2024.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.
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 #: 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# 37262e or lawson # 104516 needle iv autoguard 22g ref # 382532.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 xxxx?.

• Brand Name: 40 IN EXT W/2 VLV PORTS
• 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: 19198287
• Report Number: 9616066-2024-00643
• Device Sequence Number: 7658611
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: (01)10885403235276
• 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): 07/09/2024

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: 37262E
• Device Lot Number: 24029188
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown