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 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0413 - material separation.

Event Description

During drug fill in the syinge of 50cc plastipak syringe the stopper stuck in-side the syringe and plunger road comes out.

Event Description

During drug fill in the syringe of 50cc plastipak syringe.The stopper stuck in-side the syringe and plunger road comes out.

Manufacturer Narrative

Pr (b)(4) follow up mdr for device evaluation: two photos 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 the reported lot 2301101, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot to evaluate the plunger movement.Testing results were reviewed for lot 2301101and all results were found to be within required limits.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, no issues were found.Based on the available information we are not able to determine a definitive root cause at this time.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.Without a physical sample, this cannot be verified.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.

• 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 IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18159011
• MDR Text Key: 328390319
• Report Number: 3003152976-2023-00505
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: 303288
• Device Lot Number: 2301101
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1