MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MICROBORE¿ TRI-FUSE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ9266

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd microbore¿ tri-fuse extension set there was bulging and leaking.Report 3 of 3.Verbatim: description: ref (b)(4) event patient linen noted to be wet.Picc line leaking at t connector site, t connector cushion appeared to be bulging out.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd microbore¿ tri-fuse extension set there was bulging and leaking.Report 3 of 3.Verbatim: description: ref # (b)(4) event: patient linen noted to be wet.Picc line leaking at t connector site, t connector cushion appeared to be buldging out.

Manufacturer Narrative

H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of t connector cushion bulging out could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material mz9266 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROBORE¿ TRI-FUSE EXTENSION SET
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17443791
• MDR Text Key: 320237265
• Report Number: 9616066-2023-01615
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240782
• UDI-Public: 10885403240782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ9266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1