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

Model Number REF11448964

Device Problem Disconnection (1171)

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

Event Date 09/09/2021

Event Type  malfunction  

Event Description

Bd/alaris secondary set tubing ref 11448946, lot#20119595, tubing spontaneously disconnected from gtt chamber in operating room while infusing into patient.Tubing was not touched or being pulled when incident happened.No injury to patient.Retrieved new tubing to continue infusion.Medication during infusion was ofirmev.Fda safety report id# (b)(4).

• Brand Name: BD SECONDARY SET IV ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V/BD
• MDR Report Key: 12474866
• MDR Text Key: 271690051
• Report Number: MW5103924
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: REF11448964
• Device Lot Number: (10)20119595
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 57