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

Catalog Number 388311

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte catheter breaks.The following information was provided by the initial reporter translated from spanish to english: at the moment of accessing the vessel gets twisted and a second punch must be carried out.When you puncture the dicho punzocat material, it breaks so you have to make the change of the same.Customer provided to us the additional information below.Do all units in the lot have the same deviation? those who the customer had, all have this problem.Those we have in inventory are not checked because of not open the boxes that will be collected in return.Has there been any harm to the patient/healthcare professional? (detail).Yes, several patients had to be multipunctured several times causing discomfort and damage to the skin.1.Was there a need for medical and/or surgical intervention due to what occurred (imaging examinations, surgery, medication administration, etc.)? (detail) there was no need.2.Has there been exposure of blood or chemotherapy to the mucous membranes or skin? (detail) if you refer to the collected material, no.This material was not collected, only what was not used, but the material that was used did have contact with skin and blood.Information received on nov, 30 2023: could you clarify what enrisca would be? could it be the needle that pierced the catheter? r: enriscar refers to that it is made accordion type, it is not that the needle loses the catheter, it is that they do not come beveled to allow insertion.Would you be able to report if the catheter was difficult to advance? r: yes, the advance or the incision could not be made with the patient, the patient was even hurt when trying to place the catheter him/her.Could you clarify what it would mean to break up? r: break up is that the vialon catheter broken.

Manufacturer Narrative

Although there were no records that could cause this complaint during the analysis of the batch history and nonconformities, however, it can be seen that the adapter is slightly away from the needle barrel and the catheter is wrinkled.For a detailed analysis, the presence of the sample would be necessary.Based on investigations, it was found that a probable root cause for this incident was caused by a failure at the cannula assembly/guidance station on icam machine #03, chassis #01, as per maintenance order #( b)(4).This failure could have generated the part with the crushed cannula body that reached the chassis #02 of the icam #03 machine and would have been normally assembled as a common part, since it would not have been detected by the machine vision system or other controls.This crumpled cannula may have generated resistance when removing the catheter, wrinkling it and making puncture difficult.According to the maintenance order, adjustments were made to the alignment of the gripper position and air pressure on track #1, in order to mitigate the problem.Maintenance order attached.E1.Address information was not provided, therefore, xx was used as a place holder.

Event Description

Na.

Manufacturer Narrative

The catheter breaking is a cascading failure related to the bunching (kinking) up that occurred when they were unable to thread the catheter.While they did attempt to use the device, insertion was not successful.Reviewed by leadership who has determined that this event is not mdr reportable.

• Brand Name: BD INSYTE
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18654895
• MDR Text Key: 336063946
• Report Number: 9610048-2024-00013
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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: Other
• Device Catalogue Number: 388311
• Device Lot Number: 3062298
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/07/2024
• 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