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

Catalog Number 20350E

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

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 the bd alaris¿ smartsite¿ low sorbing extension set had a flimsy kinked area.The following information was provided by the initial reporter: fluid would not flow through filter.On (b)(6) 2023, tpn filter tubing had a kinked area flimsier than the rest of the tubing; appeared discolored/cloudy.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint that fluid would not flow through filter could not be verified due to the product not being returned for failure investigation.A device history record review for model 20350e lot number 22099098 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the bd alaris¿ smartsite¿ low sorbing extension set had a flimsy kinked area.The following information was provided by the initial reporter: fluid would not flow through filter.1/18/2023 tpn filter tubing had a kinked area flimsier than the rest of the tubing; appeared discolored/cloudy.

• Brand Name: BD ALARIS¿ SMARTSITE¿ LOW SORBING 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16389641
• MDR Text Key: 309736656
• Report Number: 9616066-2023-00225
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012256
• UDI-Public: 07613203012256
• 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
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20350E
• Device Lot Number: 22099098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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