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

Catalog Number 388336

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Phlebitis (2004)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd angiocath¿ iv catheter there was issue with phlebitis. It was stated the ¿while using the material on the patient, the catheter is stiff and patients were losing the access in vein and getting lesions. Due to this, prolongation of hospitalization was necessary because of an infection called phlebitis. Ms. (b)(6) contacted, she confirmed that there was prolongation of hospitalization, but does not know about medical intervention, if there was treatment and about the patients involved. ¿.

• Brand Name: BD ANGIOCATH¿ IV 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7494882
• MDR Text Key: 107632947
• Report Number: 9610048-2018-00052
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 388336
• Device Lot Number: 3155079
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/08/2018 Patient Sequence Number: 1