MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 300629

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 posiflush¿ normal saline syrine had flow issues.The following was received from the initial reporter: cause alarms, do not dispense medicine at the pump.Several syringes out of the package are defective.Cause pressure alarms and do not dispense medicine at the pump.There is no fault with the pumps and the correct syringe model is selected, so the cause of the problem lies in the sprayers.

Manufacturer Narrative

(b)(4) follow up mdr for device evaluation: several samples were returned to our quality team for investigation.Upon visual inspection, no damage or other defects were observed on any of the devices.A device history review was performed for reported lot 2307784, 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 2307784 and all results were found to be within required limits.The returned samples underwent the same testing all product was found to within required limits for breakout force and sustaining force, however, six samples were found to have silicone above the specified limit.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.While we could not identify a direct issue, it is possible that this issue is related to poor distribution of the silicone within the syringe, causing silicone to build up in one area which could impact the plunger movement.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.

Event Description

It was reported that the bd posiflush¿ normal saline syrine had flow issues.The following was received from the initial reporter: cause alarms and do not dispense medicine at the pump.Several syringes out of the package are defective.Cause pressure alarms and do not dispense medicine at the pump.There is no fault with the pumps and the correct syringe model is selected, so the cause of the problem lies in the sprayers.Can we request if there was any damage or other issue observed on the syringes? is there any sticking or difficulty noted in the plunger movement? ep - 1st attempt on (b)(6) 2023 2nd attempt on (b)(6) 2023 response : " the syringes have been used.They feel a bit sticky and you need to add a bit more pressure than usual when using them.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17872664
• MDR Text Key: 324963172
• Report Number: 3003152976-2023-00435
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903006298
• UDI-Public: (01)00382903006298
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300629
• Device Lot Number: 2307784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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