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

Catalog Number 10802688

Device Problems Detachment of Device or Device Component (2907); Gas/Air Leak (2946)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ smartsite¿ gravity set experienced separation causing the tubing to fill with air.The following information was provided by the initial reporter: the last patient i had whose tubing pulled apart, he had picked it up, pushed it back together and then flagged me down.I noticed the whole tubing had filled with air.

Manufacturer Narrative

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 the bd alaris¿ smartsite¿ gravity set experienced separation causing the tubing to fill with air.The following information was provided by the initial reporter: the last patient i had whose tubing pulled apart, he had picked it up, pushed it back together and then flagged me down.I noticed the whole tubing had filled with air.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22109303 d4: medical device expiration date: 26-oct-2025 h4: device manufacture date: 15-oct-2022 h6: investigation summary no product (mat # 10802688) was returned by the customer.Photo representation was provided for the complaint.It was reported by the customer the tubing pulled apart from hub and tubing broke off drip chamber when priming.The photo could not verify the complaint.The root cause cannot be determined without the physical sample for investigation.A device history record review for model 10802688 and lot number 22109303 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, and no clear pictures evidence provided an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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 ; 8448235433
• MDR Report Key: 16873201
• MDR Text Key: 314726304
• Report Number: 9616066-2023-00823
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: 10885403234439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10802688
• Device Lot Number: 22109303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2022
• 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