MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD INSYTE 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 38831114

Device Problem Break (1069)

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

Event Date 01/27/2024

Event Type  malfunction  

Event Description

It was reported that twice a bd insyte catheter was damaged during cannulation.The following information was provided by the initial reporter, translated from spanish to english: attempts are made to cannulate the patient in two occupations, catheter number 24 is damaged.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD INSYTE 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• 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: 18878086
• MDR Text Key: 337772358
• Report Number: 3003916417-2024-00069
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2024

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: Other
• Device Catalogue Number: 38831114
• Device Lot Number: 3062305
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/11/2024
• 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: Female