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

Catalog Number 303288

Device Problems Material Separation (1562); Failure to Deliver (2338)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd plastipak¿ syringe the plunger was difficult to move and stopper separation occurred.There was no report of patient impact.The following information was provided by the initial reporter: multiple pirs have been raised on the same issue as plunger movement is very hard during the loading.The incident also raised for separation of stopper and plunger.They were not facing this issue with bd 50ml precise syringe with same practice.

Manufacturer Narrative

H6: investigation summary: one photo which was previously provided by the same customer for the same lot , was evaluated.Through visual inspection, no damage or other defect can be identified within the device, however, the stopper is observed to be separated from the plunger.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 plunger moved without issue.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.

Event Description

It was reported while using bd plastipak¿ syringe the plunger was difficult to move and stopper separation occurred.There was no report of patient impact.The following information was provided by the initial reporter: multiple pirs have been raised on the same issue as plunger movement is very hard during the loading.The incident also raised for separation of stopper and plunger.They were not facing this issue with bd 50ml precise syringe with same practice.

• Brand Name: BD PLASTIPAK¿ 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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17666919
• MDR Text Key: 322481951
• Report Number: 3003152976-2023-00368
• 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,Foreign,User Facility
• 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: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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