MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE; PERIPHERAL IV CATHETER

Catalog Number 388311

Device Problem Break (1069)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.

Event Description

It was reported that bd insyte catheter broke/cracked.The following information was provided by the initial reporter, translated from spanish to english: multipuncture patient as the catheter contains a cutout which makes it impossible to advance the vessel to the multipuncture patient 11 attempts.Check the incident(s) that occurred.Broken or cracked indicate the consequence(s) of the incident indirect damage was there any harm to the patients/healthcare professionals? answer: there was no harm to the patient.Was it possible to complete the procedure? answer: yes.What was the outcome for the patient? answer: in the end there were no complications.

• Brand Name: BD INSYTE
• Type of Device: PERIPHERAL IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19112698
• MDR Text Key: 340906150
• Report Number: 9610048-2024-00038
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

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: Health Professional
• Device Catalogue Number: 388311
• Device Lot Number: 3062298
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Sex: Male