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

Catalog Number 300865

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Deformation (2976)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

It was reported while using bd plastipak¿ syringes the syringe couldn't connect properly and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the department reports that the plunger of the syringe is leaking.Problem: the chemotherapy product can pass behind the piston, with more or less leakage.Consequence: loss of product, which can lead to the need to repeat the preparation.Contamination of the environment in the isolator.The luer lock, does not grip, on the spike (secured sampling material).Problem: difficulty to connect, and the syringe disconnects consequence 1: syringe bounces and disconnects with possible projection of anticancer product and contamination of the environment in the isolator.Consequence 2: musculoskeletal disorder, the pph must repeatedly force the screwing.The incriminated device was not kept in the department but other syringes of the same batch were recovered in the medical devices functional unit, where they are at your disposal for return and expertise.We look forward to receiving your reply.

Manufacturer Narrative

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¿ syringes the syringe couldn't connect properly and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the department reports that the plunger of the syringe is leaking.Problem: the chemotherapy product can pass behind the piston, with more or less leakage.Consequence: loss of product, which can lead to the need to repeat the preparation.Contamination of the environment in the isolator.The luer lock, does not grip, on the spike (secured sampling material).Problem: difficulty to connect, and the syringe disconnects consequence 1: syringe bounces and disconnects with possible projection of anticancer product and contamination of the environment in the isolator.Consequence 2: musculoskeletal disorder, the pph must repeatedly force the screwing.The incriminated device was not kept in the department but other syringes of the same batch were recovered in the medical devices functional unit, where they are at your disposal for return and expertise.We look forward to receiving your reply.

Manufacturer Narrative

Investigation summary: no sample received for investigation.A device history review was performed for reported lot 2301015, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Retained samples the same lot were evaluated.Barrel do not present any damage that could have deformed their shape.The stopper is correctly assembled, when the syringe is disassembled the plunger does not show any defect.Further testing was conducted, no sign of leakage occurred.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, including tip and thread verification testing.Based on our investigation and given the device records did not identify any failures related to this incident, we are not able to determine a root cause related to our manufacturing process at this time.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• 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.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16657143
• MDR Text Key: 312677416
• Report Number: 3003152976-2023-00112
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/30/2023

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: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2301015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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