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

Catalog Number 10013902

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite low sorbing set separated.The following information was received by the initial reporter with the verbatim: the filter fell apart.We have two new ones today from last night.They are in my office.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17946563
• MDR Text Key: 325833508
• Report Number: 9616066-2023-02097
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233812
• UDI-Public: (01)50885403233812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10013902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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