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

Catalog Number 38181214

Device Problem Material Rupture (1546)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd insyte autoguard catheter 'rupture' during insertion process.The following information was provided by the initial reporter, translated from portuguese to english: i hereby inform you that a notification has been opened with notivisa due to a possible quality deviation, abocath showing a rupture in the silicone at the time of phlebotomy.In accordance with our internal technovigilance procedure, we are notifying you so that we can assess and adapt this incident.

Manufacturer Narrative

Event date received and additional information related to patient outcome supporting no si also added.

Event Description

Response received on 26dec2023: was there any harm to the patient/healthcare professional? no.Was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, drug administration, etc.)? no.Was there any exposure of blood or chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if so, please state whether the exposure was the patient's or the professional's and what measures were taken.No.Response received on 04jan2024.What medication was being administered? - no reports.Info received on 09jan2024.Date of event : 28/11/2023.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 18461383
• MDR Text Key: 332733573
• Report Number: 9610048-2023-00118
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 38181214
• Device Lot Number: 3132130
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/07/2024
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1