MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VENFLON PRO SAFETY 14; CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd venflon pro safety 14 separated and leaked.The following information was provided by the initial reporter: patient undergoing total intravenous anaesthesia (tiva) with propofol and remifentanil for craniotomy via 14 guage cannula sited in l saphenous vein.2 hours into the anaesthetic bolus of glycopyrrolate given to treat bradycardia.Glycopyrrolate given via hub of 14g cannula.Couple of minutes later patients heart rate, blood pressure and bispectral index started increasing.Cannula checked and noted to be leaking the propofol and remifentanil out of the hub.Hub occluded with syringe, and bolus of propofol given via alternative cannula.On further inspection the grey valve mechanism under the cannula hub had moved so that it was no longer effective.Details of injury (to patient, carer or healthcare professional): potential risk of accidental awareness under general anaesthesia (aaga) due to failure of delivery of total intravenous anaesthesia (tiva).Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): failure of cannula and anaesthetic delivery noticed promptly, bolus of iv anaesthetic (propofol) given via already sited back-up cannula to maintain anaesthesia.New cannula sited in alternative vein.Tiva switched from defective cannula to newly sited cannula.

Event Description

It was reported that unspecified bd venflon pro safety 14 separated and leaked.The following information was provided by the initial reporter: patient undergoing total intravenous anaesthesia (tiva) with propofol and remifentanil for craniotomy via 14 guage cannula sited in l saphenous vein.2 hours into the anaesthetic bolus of glycopyrrolate given to treat bradycardia.Glycopyrrolate given via hub of 14g cannula.Couple of minutes later patients heart rate, blood pressure and bispectral index started increasing.Cannula checked and noted to be leaking the propofol and remifentanil out of the hub.Hub occluded with syringe, and bolus of propofol given via alternative cannula.On further inspection the grey valve mechanism under the cannula hub had moved so that it was no longer effective.Details of injury (to patient, carer or healthcare professional): potential risk of accidental awareness under general anaesthesia (aaga) due to failure of delivery of total intravenous anaesthesia (tiva).Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): failure of cannula and anaesthetic delivery noticed promptly, bolus of iv anaesthetic (propofol) given via already sited back-up cannula to maintain anaesthesia.New cannula sited in alternative vein.Tiva switched from defective cannula to newly sited cannula.

Manufacturer Narrative

H.6.Investigation: one photo was received by our quality team for evaluation.Upon visual inspection of the photo, it was observed that the valve had moved towards the cannula hub luer side.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause of the leakage is due to the injection valve moving within the cannula hub.Capa#1379444 was initiated.

• Brand Name: UNSPECIFIED BD VENFLON PRO SAFETY 14
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11606235
• MDR Text Key: 243584325
• Report Number: 2243072-2021-00919
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1