MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 20ML LL 120/PKG

Catalog Number 300629

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 20 ml ll 120/pkg was incompatible with the syringe pump.The following information was provided by the initial reporter: "a young girl is sedated with propofol during surgery.Sedation takes place continuously and is managed by an orchestra base.The dps syringe pumps positioned on it work in relay mode.Towards the end of the procedure, a 20 ml bd plastipak syringe filled with propofol is put in place following a 50 ml bd plastipak syringe.The electric syringe pump immediately goes into over pressure alarm (even at a flow rate of 10 ml / h) while the venous route is free and of large caliber (18g venous route).The contents of the 20 ml syringe were transferred to a 50 ml syringe and everything was returned to normal.Potential dangerous risks: > risk of awakening during procedure (unpleasant or even dangerous for the patient depending on the procedure) and increased risk of contamination.".

Manufacturer Narrative

H.6.Investigation summary one sample was provided to our quality team for investigation.The product was visually inspected, no damage or molding defect was observed and the issue was identified with the plunger movement.A device history review was performed for reported lot 1910207, 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, no damage or molding defect observed.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.All retained samples were evaluated and found to be within required specifications.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.

Event Description

It was reported that syringe 20ml ll 120/pkg was incompatible with the syringe pump.The following information was provided by the initial reporter: "a young girl is sedated with propofol during surgery.Sedation takes place continuously and is managed by an orchestra base.The dps syringe pumps positioned on it work in relay mode.Towards the end of the procedure, a 20 ml bd plastipak syringe filled with propofol is put in place following a 50 ml bd plastipak syringe.The electric syringe pump immediately goes into overpressure alarm (even at a flow rate of 10 ml / h) while the venous route is free and of large caliber (18g venous route).The contents of the 20 ml syringe were transferred to a 50 ml syringe and everything was returned to normal.Potential dangerous risks: > risk of awakening during procedure (unpleasant or even dangerous for the patient depending on the procedure) and increased risk of contamination.".

• Brand Name: SYRINGE 20ML LL 120/PKG
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9758169
• MDR Text Key: 210624820
• Report Number: 3003152976-2020-00082
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 1910207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other