MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL INDIA; SYRINGE, PISTON

Catalog Number 303288

Device Problem Material Separation (1562)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

During the investigation of the product, the stopper was found to be separated from the plunger.

Manufacturer Narrative

(b)(4): initial mdr for device evaluation.During the investigation of the device, a reportable malfunction was found.Both photos and the physical sample were provided to our quality team for investigation.Through visual inspection, the stopper is observed to be separated from the plunger.There is no other visible damage or defect observed that could indicate why the separation occurred.A device history review was performed for reported lot 2303002, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.The silicone employed in this product is a medial grade and is used during the syringe assembly process to lubricate the barrel in order to help ease the movement of the plunger and stopper.Throughout the manufacturing process, break out force, sustaining force testing, and silicone content tests are conducted for each lot to evaluate the plunger movement.Results for the reported lot were reviewed and no issues were identified.Based on our investigation and sample evaluation, we are not able to determine a root cause at this time.While we could not identify a direct issue, it is possible the stopper may have separated due to a high pressure applied to the plunger, if the tip was blocked or if the flow entrance was insufficient for the volume of the syringe, which would create a vacuum effect within the syringe.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: SYRINGE 50ML LL INDIA
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18675331
• MDR Text Key: 335006382
• Report Number: 3003152976-2024-00066
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303288
• Device Lot Number: 2303002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• Type of Device Usage: Initial
• Patient Sequence Number: 1