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

Model Number 381137

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that black foreign matter was found on the bd angiocath¿ iv catheter cannula. The following information was provided by the initial reporter, translated from (b)(6) to english: "at 10 am on (b)(6) 2020, the patient with 8 beds need invasive blood pressure monitoring. During the quality inspection before the arterial puncture, a black foreign matter was found in the cannula of the disposable venous indwelling needle. Discard the indwelling needle immediately. No adverse effects on patients. ".

• 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 ; 8015296192
• MDR Report Key: 11182450
• MDR Text Key: 227475977
• Report Number: 9610048-2021-00013
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381137
• Device Catalogue Number: 381137
• Device Lot Number: 8351727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial