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 Low Blood Pressure/ Hypotension (1914)

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte needle pierced the catheter.The following information was provided by the initial reporter, translated from spanish to english: it hurts the patient and the cannulation is not performed correctly, additionally in other cases the product is not used due to defective input.Additional info received : 11 march 2024.Has any harm occurred to the patient/healthcare professional (detail)? yes, there have been different effects on the patients, among which, on monday, march 11, the input was used to acquire the sample, however, the helmet opens inside the patient, generating discomfort and a bad reaction, where his vital signs decrease and his blood pressure drops drastically, preventing the examination from continuing satisfactorily.Was there a need for medical and/or surgical intervention due to the event (imaging tests, surgery, drug administration, etc.)? (detail) the patient is referred to one of the locations where the laboratory has medical personnel to care for these cases.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• 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: 19011686
• MDR Text Key: 339126265
• Report Number: 9610048-2024-00036
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38831114
• Device Lot Number: 2237018
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other