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

Catalog Number 682245

Device Problem Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2024

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: we have had an incident while removing an arterial cannula.While removing the cannula the sheath has broken away and been left inside the radial artery.This happened on (b)(6) 2024.While removing it became entangled in the dressings and we're not sure whether this has contributed towards the breakage.To be on the safe side we have segregated the batch.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Based on the dhr review, there is an outgoing inspection to inspect for product damaged during the in-process inspection as per mfg-079/b, no catheter tubing defect qn being raise for the assembly needle (an) batch used to produce this complaint batch.1 photo was received for this complaint.Photo shows broken catheter.No sample was received.If there was a sample received, the broken catheter can be investigated to determine its cause, the complaint will be re-open when there is a sample received.The complaint trend will be monitored.

Event Description

We have had an incident while removing an arterial cannula.While removing the cannula the sheath has broken away and been left inside the radial artery.This happened on 7th march.While removing it became entangled in the dressings and we're not sure whether this has contributed towards the breakage.To be on the safe side we have segregated the batch.

• 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: 19198289
• MDR Text Key: 341240059
• Report Number: 2243072-2024-00568
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2355697
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention