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

Model Number 30914

Device Problem Material Deformation (2976)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported that prior to use with bd alaris¿ extension set the tubing was discovered to be sealed together.The following information was provided by the initial reporter: a part of the tubing is sealed together.

Manufacturer Narrative

Investigation summary: a complaint of tubing being sealed together was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing defective/ damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 30914 lot number 22089343 was performed.The search showed that a total of (b)(4) in 1 lot number were built on 17aug2022.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.

• Brand Name: BD ALARIS¿ 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 ; 8448235433
• MDR Report Key: 16465266
• MDR Text Key: 310495087
• Report Number: 9616066-2023-00290
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: (01)50885403233317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• 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
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 22089343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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