MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL

Catalog Number 300865

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2002284.Medical device expiration date: 2025-01-31.Device manufacture date: 2020-02-21.Medical device lot #: unknown.Medical device expiration date: 2025-01-31.Device manufacture date: 2020-02-21.

Event Description

It was reported that syringe 50ml ll caused alarms in the syringe pump.This led to hypertension in the patient.The following information was provided by the initial reporter: "we have a problem with certain lot numbers of bd plastipak syringes.We have recently had numerous occlusions, and i have tried to dissect the problem as below.I tried ringing but could not get through to your work mobile.I will escalate at our end and i have copied dave lyon in, in case there is an increase in reported incidents.I will also alert gitu / hdu etc.I guess incidents may not be noticed in areas where infusion rates are lower, as they will generate lower pumping pressures.Was the course of treatment changed? a- no, all patients required the same drug infusions as they were all essential.I was not really sure about this meaning of this question.All patients involved had their treatment interrupted because of the occlusions which occurred.After rectifying and removal of faulty syringes, the same treatment was recommenced.Any medical intervention performed? a.Yes.Patient 1: noradrenaline occlusion resulted in severe hypotension.Replacement syringe also faulty which compounded the situation.Medical input required to rectify this including short period of cpr.Other reports subsequent to this where other drugs, including propofol & morphine had either occluded, or pumping pressures were running very high.Other actions taken? a- rectification of underlying cause via removal of faulty syringes from cicu, noradrenaline episodes had datix completed.Comparison of different batch numbers of syringes an iv lines undertaken during process of problem identification.Syringe pumps in patient 1 sent to bme for inspection.Are the physical samples available for the investigation or photos? a- we have 3 bags full of the affected batch numbers of syringes on cicu, they have been placed out of the patient area in our seminar room.Hope this helps.".

Event Description

It was reported that syringe 50ml ll caused alarms in the syringe pump.This led to hypertension in the patient.The following information was provided by the initial reporter: "we have a problem with certain lot numbers of bd plastipak syringes.We have recently had numerous occlusions, and i have tried to dissect the problem as below.I tried ringing but could not get through to your work mobile.I will escalate at our end and i have copied dave lyon in, in case there is an increase in reported incidents.I will also alert gitu / hdu etc.I guess incidents may not be noticed in areas where infusion rates are lower, as they will generate lower pumping pressures.1.Was the course of treatment changed? a- no, all patients required the same drug infusions as they were all essential.I was not really sure about this meaning of this question.All patients involved had their treatment interrupted because of the occlusions which occurred.After rectifying and removal of faulty syringes, the same treatment was recommenced.2.Any medical intervention performed? a.Yes patient 1 ¿ noradrenaline occlusion resulted in severe hypotension.Replacement syringe also faulty which compounded the situation.Medical input required to rectify this including short period of cpr.Other reports subsequent to this where other drugs, including propofol & morphine had either occluded, or pumping pressures were running very high.3.Other actions taken? a- rectification of underlying cause via removal of faulty syringes from cicu, noradrenaline episodes had datix completed.Comparison of different batch numbers of syringes an iv lines undertaken during process of problem identification.Syringe pumps in patient 1 sent to bme for inspection 4.Are the physical samples available for the investigation or photos? a- we have 3 bags full of the affected batch numbers of syringes on cicu, they have been placed out of the patient area in our seminar room.Hope this helps.".

Manufacturer Narrative

Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported 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 lot 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.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10269514
• MDR Text Key: 201847603
• Report Number: 3003152976-2020-00301
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other