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

Model Number 20027E

Device Problem Retraction Problem (1536)

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

Event Date 10/04/2021

Event Type  malfunction  

Event Description

It was reported that the bd alaris smartsite extension set experienced component separation.The following information was provided by the initial reporter: after priming tubing for tpn the filter tubing broke in half right at filter.Tubing above was clamped in preparation to bring into patients room so no tpn was lost.Filter replaced with a new one and functioned properly.Lot: unknown.No harm.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation summary: a used sample was received and tested by our quality team.The failure type was verified as the customer reported.The set had a break where the tubing meets the filter.This has been seen in the past as a stress issue and the root cause remains unknown but has been linked to improper force applied to the junction during use.A device history record review for model 20027e could not be performed as the lot number was not provided.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd alaris smartsite extension set experienced component separation.The following information was provided by the initial reporter: after priming tubing for tpn the filter tubing broke in half right at filter.Tubing above was clamped in preparation to bring into patients room so no tpn was lost.Filter replaced with a new one and functioned properly.Lot: unknown.No harm.

• Brand Name: BD ALARIS SMARTSITE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12920091
• MDR Text Key: 284987024
• Report Number: 9616066-2021-52529
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234857
• UDI-Public: 50885403234857
• 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: 03/16/2022

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
• Device Operator: Other
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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