MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported that bd syringe was incompatible with pump.The following information was received by the initial reporter with the verbatim: occlussion alarm in fresenius agilia tiva syringe pump the syringes have been used with different fresenius agilia tiva syringe pumps.The complainant have encountered persistent issues related to intermittent occlusion alarms, which lack any clinical explanation and occur at different times during the anesthesia process.The alarms triggered by the syringes are raising concerns about their reliability and performance.Despite following the prescribed guidelines and best practices, the customer have been unable to identify any obvious correlating factors or underlying causes for these alarms, the only common denominator therefor being the bd plastipak¿ syringes.This lack of clarity is affecting the efficiency of the anesthesia procedures and potentially compromising patient safety in their setting.The complainant reports that when changing from bd plastipak¿ to bd® syringe the alarms disappears, which suggests there is a difference of some sort between these syringes.No obvious pump issues or faulty pump settings was observed.Samples of the tiva set most commonly used at the clinic are being sent together with the syringe samples to aid with the investigation.Contaminated with propofol.Event occurred during use.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

(b)(4).Follow up mdr for device evaluation: several samples were returned to our quality team for investigation, including three samples of lot 2304740.Upon visual inspection, no damage or other defects were observed on any of the devices, all stoppers were verified to be properly assembled, and the plungers moved without issue.A device history review was performed for reported lot 2304740, no deviations or non-conformances related to this issue were identified during the manufacturing process.Lubricant is employed during the syringe assembly process, the silicone helps facilitate easier movement of the plunger and stopper.The silicone employed in this product is a medical grade silicone authorized for product use.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot to evaluate the plunger movement and ensure the proper quantity of silicone within the product.Testing results were reviewed for lot 2304740 and all results were found to be within required limits.The returned samples underwent the same testing and all product was verified to be within required specification.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 device and reported condition will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that bd syringe was incompatible with pump.The following information was received by the initial reporter with the verbatim: occlusion alarm in fresenius agilia tiva syringe pump the syringes have been used with different fresenius agilia tiva syringe pumps.The complainant have encountered persistent issues related to intermittent occlusion alarms, which lack any clinical explanation and occur at different times during the anesthesia process.The alarms triggered by the syringes are raising concerns about their reliability and performance.Despite following the prescribed guidelines and best practices, the customer have been unable to identify any obvious correlating factors or underlying causes for these alarms, the only common denominator therefor being the bd plastipak¿ syringes.This lack of clarity is affecting the efficiency of the anesthesia procedures and potentially compromising patient safety in their setting.The complainant reports that when changing from bd plastipak¿ to bd® syringe the alarms disappears, which suggests there is a difference of some sort between these syringes.No obvious pump issues or faulty pump settings was observed.Samples of the tiva set most commonly used at the clinic are being sent together with the syringe samples to aid with the investigation.Contaminated with propofol.Event occurred during use.

• Brand Name: BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17833738
• MDR Text Key: 324466750
• Report Number: 3003152976-2023-00422
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2304740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1