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

Catalog Number 38831114

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/23/2024

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.

Event Description

It was reported that bd insyte catheter tip breaks.The following information was provided by the initial reporter, translated from spanish to english: at the time of patient channeling, two #24 catheters are used in which it is evident that when introduced the bevel does not break the skin properly, causing it not to advance and damage the access, they also flourish at the tip of the catheter easily alternate translation from google translate: at the moment of carrying out patient channels, two #24 catheters are used in which it is evident that when inserting them the bevel does not adequately break the skin, causing it not to advance and access is damaged, also they break at the tip of the catheter easily.Delay in procedure and treatment.

• 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 IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18937474
• MDR Text Key: 338596379
• Report Number: 9610048-2024-00032
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903883110
• UDI-Public: (01)00382903883110
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 38831114
• Device Lot Number: 3062305
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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