MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE 18GA X 1.16IN; PERIPHERAL IV CATHETERS

Catalog Number 38831714

Device Problem Material Puncture/Hole (1504)

Patient Problem Phlebitis (2004)

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Other potential lot numbers include 3194195 with expiration date 2028-07-31, and 3241011 with expiration date 09/30/2028.If a device evaluation and/or device history review is completed, a supplemental report will be filed.Other potential lot number device manufacture dates include 2023-08-09 and 10/04/2023.

Event Description

It was reported that the bd insyte 18ga x 1.16in needle went through the catheter.The following information was provided by the initial reporter translated from spanish to english: "we have received notification of adverse incidents with the bd insyte intravenous catheter of 24, 18, 20 gauge.In particular, we have been informed that the iv catheter no.24 lot 3062305 fv 02/2028 at the moment of unclogging the catheter, the catheter was checked, and the mandrel was observed to be perforated by the needle.The icu service reports an increase in cases of mechanical phlebitis." additional information received apr 09 2024 what is the quantity affected? rt/ the novelty of the devices has been presented in the catheter no.18,22,20 and 24 in the areas of uci emergency and pediatrics.However, 2 cases have been formally reported with catheter no.24 and 2 cases with catheter no.18.What is the lot number of the product? r/ catheter 18 lot: 3194195 expiry date 30/07/2028 - 3241011 expiry date 33/08/2028 was the reported incident detected before, during or after use on the patient? r/ before use on patient and in use on patient, generating phlebitis.Has there been any harm to the patient/healthcare professional? r/ phlebitis has occurred in the veins of a multi-punctured patient.- was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, medication administration, etc.)? (detail) for the moment no - has there been exposure of blood/chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if yes, indicate whether the exposure was from the patient or the practitioner and what measures were taken.(detail) for the time being no - what medication was being administered? r/ medication was not administered as there was evidence of damage at the time of channeling the patient.- is the sample related to the incident available for analysis? if yes, report the quantity.R/ the catheters have been discarded.- could you please send photo samples of the specimen? the following photos are sent as evidence: - o date of incident: march 29, march 30 and april 2 of the current year:.

• Brand Name: BD INSYTE 18GA X 1.16IN
• 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: 19193737
• MDR Text Key: 341926438
• Report Number: 9610048-2024-00041
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903883172
• UDI-Public: (01)00382903883172
• 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,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/16/2024

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: 38831714
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1