MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 393229

Device Problem Leak/Splash (1354)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 04/09/2021

Event Type  Death  

Manufacturer Narrative

Initial reporter phone #: (b)(4).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 that the bd venflon" pro safety shielded iv catheter experienced leakage from the injection port, and was involved with a patient death.The patient had extremely low blood pressure, and went into peri-cardiac arrest.The patient could not be resuscitated due to the device failure.Surgical intervention was administered, and under continually unstable conditions, the patient died post-operatively.The following information was provided by the initial reporter: i have had a complaint from the following customer in respect to a 16g venflon pro safety catheter.She advised that it was a very serious incident i have no further details as it was a very brief conversation but she confirmed she would send further details but i wanted to ensure that this was logged.It was a 16 g pro safety cannula sited anterior chest wall due to very poor vascular access.We have had many similar incidents with the pro safety cannulas recently and this follows the same pattern.Unstable patient needing general anaesthesia (ga) to repair bleeding abdominal aortic aneurysm.Last of ga drugs injected into top of cannula and pop felt and fluid poured out of the top of the cannula.This cannula was connected to a rapid infuser which was primed with blood products.A cannula cap was put on top of the cannula but popped off.Therefore a smartsite was screwed into the cannula port to stem the flow of fluid and drugs out of the cannula but this resulted in cannula occlusion and failure of rapid infuser  back pressure caused fluids to pour out of reservoir.Infuser unable to be used and primed blood products were discarded  2 units of packed red cells and 2 units of ffp.Consultant anaesthetist aware of cannula problems due to eo sterilization but due to urgency of situation the nearest cannula was used.Decision not to use 3-way tap as fluids were being bolused in simultaneously to resuscitate patient.Patient peri-cardiac arrest after this  systolic bp 40mmhg.18g cannula inserted and patient received iv adrenaline to resuscitate.Surgery was undertaken  patient continued to be very unstable and died post-operatively.Has there been any serious injury? as above  patient had extremely low blood pressure  peri-cardiac arrest.Resuscitation could not continue due to failure of cannula.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the verbatim from the customer, the probable root cause for the leakage is most likely to be related to the modification in the injection port valve dimensions to accommodate ethylene oxide (eto) sterilization.A field safety notice has been issued on the possible clinical impact and advice for clinical users.Capa#: 1379444 was initiated.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter experienced leakage from the injection port, and was involved with a patient death.The patient had extremely low blood pressure, and went into peri-cardiac arrest.The patient could not be resuscitated due to the device failure.Surgical intervention was administered, and under continually unstable conditions, the patient died post-operatively.The following information was provided by the initial reporter: i have had a complaint from the following customer in respect to a 16g venflon pro safety catheter.She advised that it was ¿a very serious incident¿ i have no further details as it was a very brief conversation but she confirmed she would send further details but i wanted to ensure that this was logged.It was a 16 g pro safety cannula sited anterior chest wall due to very poor vascular access.We have had many similar incidents with the pro safety cannulas recently and this follows the same pattern.Unstable patient needing general anaesthesia (ga) to repair bleeding abdominal aortic aneurysm.Last of ga drugs injected into top of cannula and pop felt and fluid poured out of the top of the cannula.This cannula was connected to a rapid infuser which was primed with blood products.A cannula cap was put on top of the cannula but popped off.Therefore a smartsite was screwed into the cannula port to stem the flow of fluid and drugs out of the cannula but this resulted in cannula occlusion and failure of rapid infuser back pressure caused fluids to pour out of reservoir.Infuser unable to be used and primed blood products were discarded 2 units of packed red cells and 2 units of ffp.Consultant anaesthetist aware of cannula problems due to eo sterilization but due to urgency of situation the nearest cannula was used.Decision not to use 3-way tap as fluids were being bolused in simultaneously to resuscitate patient.Patient peri-cardiac arrest after this systolic bp 40mmhg.18g cannula inserted and patient received iv adrenaline to resuscitate.Surgery was undertaken patient continued to be very unstable and died post-operatively.Has there been any serious injury? as above patient had extremely low blood pressure peri-cardiac arrest.Resuscitation could not continue due to failure of cannula.

• Brand Name: BD VENFLON PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11810572
• MDR Text Key: 250167072
• Report Number: 8041187-2021-00399
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/20/2021

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: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 393229
• Device Lot Number: 0051728
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death