MAUDE Adverse Event Report: BECTON DICKINSON GRAV BLD SET 200MF 20 DP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10387509
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	11/26/2024
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.
Event or Problem Description
Material# 10387509; batch# unknown.It was reported by customer that hello today we received an additional report of an inverted filter on the 200 micron filter blood gravity set ref# (b)(4).It is imperative that we do not retain defective sets in our environment as this is hindering timely patient care and causing unnecessary waste of blood products.Verbatim: rcc received a complaint via email.Hello today we received an additional report of an inverted filter on the 200 micron filter blood gravity set ref# (b)(4).It is imperative that we do not retain defective sets in our environment as this is hindering timely patient care and causing unnecessary waste of blood products.
Additional Manufacturer Narrative
The provided photo only reflects the label of the package it does not identify a failure.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.The manufacturing site was notified of the failure, but no actions were able to be taken.A device history record review could not be performed on material 10387509 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.
Event or Problem Description
Material# 10387509, batch# unknown.It was reported by customer that hello today we received an additional report of an inverted filter on the 200 micron filter blood gravity set ref#(b)(4).It is imperative that we do not retain defective sets in our environment as this is hindering timely patient care and causing unnecessary waste of blood products.Verbatim: rcc received a complaint via email.Email(s) attached.Hello today we received an additional report of an inverted filter on the 200 micron filter blood gravity set ref#(b)(4).It is imperative that we do not retain defective sets in our environment as this is hindering timely patient care and causing unnecessary waste of blood products.

• Brand Name: GRAV BLD SET 200MF 20 DP
• 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: 20893133
• Report Number: 9616066-2024-02003
• Device Sequence Number: 21001528
• Product Code: FPA
• UDI-Device Identifier: 10885403234217
• UDI-Public: (01)10885403234217
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 01/20/2025

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: 10387509
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/23/2025
• 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