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

Catalog Number 303288

Device Problem Material Separation (1562)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 while using the bd plastipak¿ syringes the stopper and plunger detached.The following was received by the initial reporter: received the complaint from hospital purchase department regarding pediatric intensive care unit on bd plastipak 50ml syringe, while reloading the syringe the stopper and plunger detaches.High pressure required to pull the plunger as it is very hard.

Manufacturer Narrative

H.6.Investigation summary: one photo was provided to our quality team for investigation.Through visual inspection, the stopper is observed to be disassembled from the plunger rod.No damage or other defects that could lead to the stopper separating could be identified.A device history review was performed for reported lot 2301100, 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 help ease the movement of the plunger.Retained samples of the same lot were used for additional evaluation.The products were visually inspected, no issues were observed and the stopper was verified to be properly assembled onto the plunger rod.Throughout the manufacturing process, break out force, sustaining force testing, and silicone content testing are conducted for each lot to evaluate the movement of the plunger.Results for the reported lot were reviewed and no issues were identified.The retained samples underwent these same evaluations and all product was verified to meet required specifications.Based on our investigation, we are not able to determine a root cause related to the manufacturing process 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 while using the bd plastipak¿ syringes the stopper and plunger detached.The following was received by the initial reporter: received the complaint from hospital purchase department regarding pediatric intensive care unit on bd plastipak 50ml syringe, while reloading the syringe the stopper and plunger detaches.High pressure required to pull the plunger as it is very hard.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17494544
• MDR Text Key: 320787170
• Report Number: 3002682307-2023-00243
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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: 2301100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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