MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	DYNDTN1545
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd iv gravity set; foreign matter noted.The following information was provided by the initial reporter: issue - particulates on component before use.
Additional Manufacturer Narrative
The customer reported foreign matter and returned one photo and one unused sample of material dyndtn1545, lot 24015194.The sample was examined, and the complaint was verified as foreign matter.The foreign matter is a piece of tape that was stuck and wrapped around the tip of the spike.The spike is a supplier component, so the supplier was notified of the failure.The sample was forwarded to the supplier of the spike/drip chamber component.The supplier found that the root cause is the machine operator used the wrong procedure to seal the internal bag in which the drip chambers are packaged.This prompted a retraining of all machine operators who worked during manufacture of supplier lot 5648/23, about the correct usage of the instruments made for cutting the tape.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material #: dyndtn1545, batch#: 24015194.It was reported by customer that articulates on component.Verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.Issue - particulates on component.Item -dyndtn1545, lot - 24015194.

• Brand Name: BD GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• 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: 20440171
• Report Number: 9616066-2024-01474
• Device Sequence Number: 18140177
• Product Code: FPA
• UDI-Device Identifier: 20080196760029
• UDI-Public: (01)20080196760029(11)240110(17)270110(10)24015194
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: Other
• Device Catalogue Number: DYNDTN1545
• Device Lot Number: 24015194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown