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

Catalog Number 381137

Device Problem Leak/Splash (1354)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd angiocath¿ iv catheter experienced a cracked/broken catheter adapter/connector.The following information was provided by the initial reporter: on october 14, the patient needed to have invasive blood pressure monitoring indwelling due to his condition.During the use of the catheter, the posterior trocar of the arterial puncture needle was broken, so a new indwelling needle and puncture site were replaced, and invasive blood pressure monitoring was re-indwelling.

Event Description

It was reported that the bd angiocath¿ iv catheter experienced a cracked/broken catheter adapter/connector.The following information was provided by the initial reporter: on october 14, the patient needed to have invasive blood pressure monitoring indwelling due to his condition.During the use of the catheter, the posterior trocar of the arterial puncture needle was broken, so a new indwelling needle and puncture site were replaced, and invasive blood pressure monitoring was re-indwelling.

Manufacturer Narrative

H6: 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.A review of the device history record was performed and no quality issues were found during production.See h10.

• 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
• MDR Report Key: 11158990
• MDR Text Key: 227923351
• Report Number: 9610048-2021-00006
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: 00382903811373
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 381137
• Device Lot Number: 9115758
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1