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 Separation Problem (4043)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 21119582, medical device expiration date: 24-nov-2024, device manufacture date: 11-nov-2021, medical device lot #: 22059241, medical device expiration date: 17-may-2025, and device manufacture date: 17-may-2022.

Event Description

It was reported that 2 bd alaris¿ smartsite¿ low sorbing set separated causing it to leak.The following information was provided by the initial reporter: customer called and stated that the "connection to tubing detached after filter disc".Doe: 01/10/2023.Customer stated that this happened while infusing a patient.It leaked, causing chemo spill.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16298403
• MDR Text Key: 308841156
• Report Number: 9616066-2023-00136
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233814
• UDI-Public: 10885403233814
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10013902
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• 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