MAUDE Adverse Event Report: BECTON DICKINSON EXT SET DEHP FREE 1.2MF; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10012866
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material # 10012866 , batch # 24019396.It was reported by customer that 1.2 micron filtered tubing sets are backing up with nicu patients.Verbatim: rcc received a complaint via phone.Pir attached.1.2 micron filtered tubing sets are backing up with nicu patients.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint that there was back flow could not be verified due to the product not being returned for failure investigation.A device history record review for model 10012866 lot number 24019396 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
No additional info.

• Brand Name: EXT SET DEHP FREE 1.2MF
• 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: 19309085
• Report Number: 9616066-2024-00733
• Device Sequence Number: 11515510
• Product Code: FPA
• UDI-Device Identifier: 10885403233777
• UDI-Public: (01)10885403233777
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 06/05/2024

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: 10012866
• Device Lot Number: 24019396
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown