MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number 386801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  Injury  

Event Description

It was reported while using bd cathena safety iv catheter with bd multiguard technology blood could not be drawn from the catheter.The following information was provided by the initial reporter: what was the level of harm?: harm or clinically serious adverse event multiple peripheral iv's in place each iv catheter was a style that reduces backflow of blood with small white stoppers in the hub.Were unable to draw a vbg either by venipuncture (physiology of pt) or from iv catheter sites.The patient had a clinical deterioration of which we could not monitor point of care blood work.Who was affected? patient.

Manufacturer Narrative

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 while using bd cathena safety iv catheter with bd multiguard technology blood could not be drawn from the catheter.The following information was provided by the initial reporter: what was the level of harm?: harm or clinically serious adverse event.Multiple peripheral iv's in place each iv catheter was a style that reduces backflow of blood with small white stoppers in the hub.Were unable to draw a vbg either by venipuncture (physiology of pt) or from iv catheter sites.The patient had a clinical deterioration of which we could not monitor point of care blood work.Who was affected? patient.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h.10.

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13877735
• MDR Text Key: 288114222
• Report Number: 8041187-2022-00145
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172506
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 386801
• Device Catalogue Number: 386801
• Device Lot Number: 9165828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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