MAUDE Adverse Event Report: BECTON DICKINSON BD ARTERIAL CANNULA 20G/45MM; INTRAVASCULAR CATHETER

Catalog Number 682245

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that bd arterial cannula 20g/45mm catheter broke / separated after placement.The following information was provided by the initial reporter: description of incident: on arrival to ccu post operatively patients arterial line started to bleed.Pressure applied and nurse called for help.On removal of the gauze when bleeding stopped it was noted that the arterial line had snapped and retained within the patient¿s artery.The patient had to be returned to theatre to have this removed under local anaesthetic confirmation of a product fault/failing.

Manufacturer Narrative

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 numbers 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.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.

• Brand Name: BD ARTERIAL CANNULA 20G/45MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18991798
• MDR Text Key: 338886337
• Report Number: 2243072-2024-00452
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382906822451
• UDI-Public: (01)00382906822451
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: 2309336
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention