MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38833314

Device Problem Material Separation (1562)

Patient Problem Abrasion (1689)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd angiocath¿ peripheral venous catheter the catheter broke during use and remained in the patient.Surgery was required to remove the material.The following information was provided by the initial reporter: it is breaking in the act of withdrawal."at the time of removal of the catheter to perform the exchange of peripheral access, the device broke in the middle of the silicone and a part remained in the patient's vessel, requiring a surgical procedure for removal." was the reported incident noticed before, during or after use? during use.Was there any harm to the patient/health worker? (detail)? according to the information above, it was necessary to send the patient to the operating room in order to remove the material from the patient's vessel.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail)? yes, as reported above.Has there been blood or chemotherapy exposure to mucous membranes or skin? (detail)? there was blood exposure.

Manufacturer Narrative

Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h10.

Event Description

It was reported while using bd angiocath¿ peripheral venous catheter the catheter broke during use and remained in the patient.Surgery was required to remove the material.The following information was provided by the initial reporter: it is breaking in the act of withdrawal."at the time of removal of the catheter to perform the exchange of peripheral access, the device broke in the middle of the silicone and a part remained in the patient's vessel, requiring a surgical procedure for removal." ¿ was the reported incident noticed before, during or after use? during use ¿ was there any harm to the patient/health worker? (detail).According to the information above, it was necessary to send the patient to the operating room in order to remove the material from the patient's vessel.¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail).Yes, as reported above.¿ has there been blood or chemotherapy exposure to mucous membranes or skin? (detail) there was blood exposure.

• Brand Name: BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14502902
• MDR Text Key: 292727227
• Report Number: 9610048-2022-00045
• Device Sequence Number: 1
• Product Code: FOZ
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: 38833314
• Device Lot Number: 1299272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention