MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE

Catalog Number 300865

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

Patient Problem Cardiac Arrest (1762)

Event Date 03/23/2021

Event Type  Death  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2009086, medical device expiration date: 2025-08-31, device manufacture date: 2020-09-23.Medical device lot #: 2011008, medical device expiration date: 2025-10-31, device manufacture date: 2020-10-30.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 plastipak" concentric luer lock syringe was used with norepinephrine to manually purge the lines of a "post-fibroscopy/aspiration" patient after experiencing a drop in blood pressure.However, despite a rise in blood pressure, the patient remained unresponsive, and a new infusion line was installed.Lines were purged once more, the syringes were changed, and "cisatracurim" was started, but the patient's blood pressure dropped again.An "adrenaline bolus" was administered, but the patient remained unresponsive, and eventually passed away the same day.The following information was provided by the initial reporter, translated from french to english: "post-fibroscopy/aspiration blood pressure drop in a covid + intubated/ventilated icu patient.Discontinuation of anti-hypertensive drugs connected to the medial line of the triluminal central venous catheter (urapidil and loxen).Disconnection of the proximal line (insulin, chlorpromazine, levomepromazine).Set up a new infusion line on the proximal line (2-way extension with bi-directional valves and non-return valves, tap with bi-directional valves to which g5% is connected on one line and norepinephrine on the other line).Purge the lines manually with norepinephrine and g5% without difficulty or particular resistance.Stop propofol with increased sedation (midazolam and sufentanyl).Administration of norepinephrine: patient unresponsive, increase flow rates patient unresponsive.Disconnect line and administer norepinephrine proximally by manual syringe, patient's blood pressure rises.Suspicion of a malfunction of this line: absence of occlusion alarm, call to the biomedical service to check the syringe pump.Absence of visualization of the advance of the drops at the end of the multichannel extender despite a flow rate of 13 ml/h.Disconnection of the multichannel extension: visualization of the drops at the end of the extension of the syringe pump.A posteriori, the extensions were tested manually with the syringe that was in the syringe pump and the solution flowed solution flowed well.Installation of a new infusion line on the proximal line (3-way extension with bidirectional valves and non-return valves, tap with bidirectional valves on which is connected g5% in syringe pump and noradrenaline in syringe pump on the other line).(noradrenaline is connected to one line), all lines are purged, syringes are changed and the patient's proximal line is connected.Cisatracurim started but patient did not respond, flow rates increased but patient did not respond.Further fall in blood pressure, increased noradrenaline flows but no response from the patient.Administration of adrenaline bolus on the peripheral catheter, no reaction from the patient.Patient died." measures taken - actions taken for the patient in relation to the device: during the incident the suspected line was completely changed.Actions taken in the establishment: the 3 syringe pumps were sent to the manufacturer for expertise.We had a serious adverse event in intensive care on (b)(6).We have not identified where the problem came from.From the point of view of expertise, the syringe pumps were sent to the manufacturer for expertise, and i have kept the multi-channel extensions, the syringe pump extensions, the syringes and the taps in my office.The 3-way catheter was not kept.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-24.H6: investigation summary: one sample was provided to our quality team for investigation.The product was visually inspected, no damage or molding defects were observed on the syringe or any components that could have contributed to the reported issue, the stopper was verified to be properly assembled onto the plunger rod, and no issues related to the movement of the plunger were identified.A device history review was performed for suspected lots 2009086 and 2011008, no deviations or non-conformances related to this issue were identified during the manufacturing process.Ten retained samples of each lot were used for additional evaluation.All product was visually inspected, no damage or defects was observed on any of the syringes or syringe components.The silicone employed in this product is a medial grade and is used during the syringe assembly process to lubricate the cylinders in the silicone station in order to help ease the movement of the plunger.Throughout the manufacturing process, break out force, sustaining force testing, and silicone content tests are conducted for each lot.Results for the reported lot were reviewed for lots 2009086 and 2011008 and no issues were identified.Testing was also performed on the returned sample along with the retained samples of each lot and all product was confirmed to be within required specifications.Based on our investigation and sample evaluation, we are not able to determine a root cause related to our manufacturing process at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe was used with norepinephrine to manually purge the lines of a "post-fibroscopy/aspiration" patient after experiencing a drop in blood pressure.However, despite a rise in blood pressure, the patient remained unresponsive, and a new infusion line was installed.Lines were purged once more, the syringes were changed, and "cisatracurim" was started, but the patient's blood pressure dropped again.An "adrenaline bolus" was administered, but the patient remained unresponsive, and eventually passed away the same day.The following information was provided by the initial reporter, translated from french to english: "post-fibroscopy/aspiration blood pressure drop in a covid + intubated/ventilated icu patient.Discontinuation of anti-hypertensive drugs connected to the medial line of the triluminal central venous catheter (urapidil and loxen).Disconnection of the proximal line (insulin, chlorpromazine, levomepromazine).Set up a new infusion line on the proximal line (2-way extension with bi-directional valves and non-return valves, tap with bi-directional valves to which g5% is connected on one line and norepinephrine on the other line).Purge the lines manually with norepinephrine and g5% without difficulty or particular resistance.Stop propofol with increased sedation (midazolam and sufentanyl).Administration of norepinephrine: patient unresponsive, increase flow rates patient unresponsive.Disconnect line and administer norepinephrine proximally by manual syringe, patient's blood pressure rises.Suspicion of a malfunction of this line: absence of occlusion alarm, call to the biomedical service to check the syringe pump.Absence of visualization of the advance of the drops at the end of the multichannel extender despite a flow rate of 13 ml/h.Disconnection of the multichannel extension: visualization of the drops at the end of the extension of the syringe pump.A posteriori, the extensions were tested manually with the syringe that was in the syringe pump and the solution flowed solution flowed well.Installation of a new infusion line on the proximal line (3-way extension with bidirectional valves and non-return valves, tap with bidirectional valves on which is connected g5% in syringe pump and noradrenaline in syringe pump on the other line).(noradrenaline is connected to one line), all lines are purged, syringes are changed and the patient's proximal line is connected.Cisatracurim started but patient did not respond, flow rates increased but patient did not respond.Further fall in blood pressure, increased noradrenaline flows but no response from the patient.Administration of adrenaline bolus on the peripheral catheter, no reaction from the patient.Patient died".Measures taken - actions taken for the patient in relation to the device: - during the incident the suspected line was completely changed.Actions taken in the establishment: - the 3 syringe pumps were sent to the manufacturer for expertise.We had a serious adverse event in intensive care on (b)(6).We have not identified where the problem came from.From the point of view of expertise, the syringe pumps were sent to the manufacturer for expertise, and i have kept the multi-channel extensions, the syringe pump extensions, the syringes and the taps in my office.The 3-way catheter was not kept.

• Brand Name: BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11794192
• MDR Text Key: 249646692
• Report Number: 3003152976-2021-00254
• Device Sequence Number: 1
• Product Code: FMF
• 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: 06/28/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300865
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death