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

Catalog Number	MZXT5307
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd extension set was leaking the following information was received by the initial reporter with the following verbatim: customer shared that the extension set at the t-port connection was leaking blood during aspirating.Or it would leak saline.Customer said this has happened on 8 extension sets opened by nurses in the ed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: mzxt5307 batch#23119255.It was reported by customer that customer shared that the extension set at the t-port connection was leaking blood during aspirating.Or it would leak saline.Customer said this has happened on 8 extension sets opened by nurses in the ed.Verbatim: customer shared that the extension set at the t-port connection was leaking blood during aspirating.Or it would leak saline.Customer said this has happened on 8 extension sets opened by nurses in the ed.
Additional Manufacturer Narrative
It was reported by the customer that the extension set at the t-port connection was leaking blood during aspirating.One photo of material number mzxt5307 was submitted for quality investigation.Evaluation of the photo shows an extension set within a plastic bag.The photo does not show the reported leakage.The customer complaint of leakage could not be confirmed.Due to no physical sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model mzxt5307 lot number 23119255 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22nov2023.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.H3 other text : see narrative below.

• Brand Name: BD EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 18674929
• Report Number: 9616066-2024-00211
• Device Sequence Number: 7395389
• Product Code: FPA
• UDI-Device Identifier: 10885403471155
• UDI-Public: (01)10885403471155
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• 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): 04/05/2024

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: Other
• Device Catalogue Number: MZXT5307
• Device Lot Number: 23119255
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown