MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML LUER-LOK SYRINGE

Catalog Number 300865

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2002299.Medical device expiration date: 2025-01-31.Device manufacture date: 2020-03-02.Medical device lot #: 2002284.Medical device expiration date: 2025-01-31.Device manufacture date: 2020-02-21.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd plastipak¿ 50ml luer-lok syringe was used and the patient blood pressure dropped repeatedly.The norad pump alarmed occlusion on multiple occasions during use.The following information was provided by the initial reporter: patient arrived from cardiac theatres at 19:15 16.6.20 following cabgx4.Initially patient hemodynamically stable.At around 20:00 patient spontaneously dropped blood pressure to 60-70 systolic- iv fluid boluses given and noradrenaline increased.At approx.20:30 patient significantly dropped bp again to 50-60 systolic and norad pump alarmed 'occlusion'.Again, iv fluid given and norad increased.Nurse in charge advised to change noradrenaline syringe at this point as recent similar incidents had happened with other patients on the unit relating to noradrenaline.I drew up another syringe of noradrenaline, new electrocath, pump and lumen on the cvc was used.Patient continued to be hemodynamically unstable overnight and on numerous times dropped blood pressure but norad pump did not alarm.The patient was then treat as hypovolemic and iv fluid (4l) was given overnight.At approx.04:10 patient again significantly dropped bp to 30 systolic- inadequate cardiac output but no change to ecg trace on monitor.Approx 30 seconds of cpr commenced and iv fluid given.Norad pump then alarmed 'occlusion' again.Metaraminol boluses given by anaesthetist and patient bp rose to 60-70 systolic and remained like this until approx 04:30.Norad syringe, pump, line and lumen changed again.Patient then remained stable until the end of my shift at 07:30.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).As stated in description, norad pump, syringe, line and lumen on cvc was changed at each time pump alarmed 'occlusion'.Anaesthetist surgeon was contacted and aware of patients instability regularly overnight and patient was reviewed by surgeon when bp dropped.Cxr performed at approx 22:00 and echo performed at 04:30.Nurse in charge aware of patient overnight and clinical educator informed in the morning to conduct investigation.Confirmed details above.Patient stabilised once syringe changed.A sample of all lot numbers and infusion lines tested.Confirmed it was not the infusion pumps (serial no infusion pumps 03743/03483), however infusion pumps sent to bme just for clarification.Further incident datix w209641 on the 17/6/20 with the same issue.Syringe changed and patient stabilised.All syringes with batch numbers 2002299 & 2002284 removed.Escalated to appropriate personnel.Staff informed via email and poster displayed on unit.Discussed with procurement 18/6/20 re-supply of alternative syringes.Will ring bd plastipak and also escalate to medical safety device committee for ongoing plan.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lots 2002299 and 2002284, no deviations or non-conformances related to this issue were identified during the manufacturing process.Ten retained samples of the same lot were used for evaluation.The product was visually inspected and no damage or molding defect observed on any of the product.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.Testing results were reviewed for lots 2002299 and 2002284 and all results were found to be within required limits.Additionally, all retained samples were evaluated and found to be within required specifications.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that bd plastipak¿ 50ml luer-lok syringe was used and the patient blood pressure dropped repeatedly.The norad pump alarmed occlusion on multiple occasions during use.The following information was provided by the initial reporter: patient arrived from cardiac theatres at 19:15 (b)(6) 2020 following cabgx4.Initially patient hemodynamically stable.At around 20:00 patient spontaneously dropped blood pressure to 60-70 systolic- iv fluid boluses given and noradrenaline increased.At approx.20:30 patient significantly dropped bp again to 50-60 systolic and norad pump alarmed 'occlusion'.Again, iv fluid given and norad increased.Nurse in charge advised to change noradrenaline syringe at this point as recent similar incidents had happened with other patients on the unit relating to noradrenaline.I drew up another syringe of noradrenaline, new electrocath, pump and lumen on the cvc was used.Patient continued to be hemodynamically unstable overnight and on numerous times dropped blood pressure but norad pump did not alarm.The patient was then treat as hypovolemic and iv fluid (4l) was given overnight.At approx.04:10 patient again significantly dropped bp to 30 systolic- inadequate cardiac output but no change to ecg trace on monitor.Approx 30 seconds of cpr commenced and iv fluid given.Norad pump then alarmed 'occlusion' again.Metaraminol boluses given by anaesthetist and patient bp rose to 60-70 systolic and remained like this until approx 04:30.Norad syringe, pump, line and lumen changed again.Patient then remained stable until the end of my shift at 07:30.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).As stated in description, norad pump, syringe, line and lumen on cvc was changed at each time pump alarmed 'occlusion'.Anaesthetist surgeon was contacted and aware of patients instability regularly overnight and patient was reviewed by surgeon when bp dropped.Cxr performed at approx 22:00 and echo performed at 04:30.Nurse in charge aware of patient overnight and clinical educator informed in the morning to conduct investigation.Confirmed details above.Patient stabilised once syringe changed.A sample of all lot numbers and infusion lines tested.Confirmed it was not the infusion pumps (serial no infusion pumps 03743/03483), however infusion pumps sent to bme just for clarification.Further incident datix w209641 on the (b)(6) 2020 with the same issue.Syringe changed and patient stabilised.All syringes with batch numbers 2002299 & 2002284 removed.Escalated to appropriate personnel.Staff informed via email and poster displayed on unit.Discussed with procurement (b)(6) 2020 re-supply of alternative syringes.Will ring bd plastipak and also escalate to medical safety device committee for ongoing plan.

• Brand Name: BD PLASTIPAK 50ML LUER-LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10272115
• MDR Text Key: 200460373
• Report Number: 3003152976-2020-00307
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other