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

Catalog Number 300629

Device Problem Leak/Splash (1354)

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

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 the bd plastipak¿ luer-lok¿ syringe leaked past the stopper during use.The following information was provided by the initial reporter: "piston appears to be not tight during winding.When winding, liquid has leaked into the rear area of the syringe.".

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe leaked past the stopper during use.The following information was provided by the initial reporter: "piston appears to be not tight during winding.When winding, liquid has leaked into the rear area of the syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jul-2022.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed.The product was further evaluated, no damaged was identified in the barrel or other components that could have caused a leak and the stopper was verified to be properly assembled onto the plunger rod.A device history review was performed for the reported lot 2105071, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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 leakage testing.The returned sample underwent the same tests and product met required specifications.Given that we did not observe any defect within the syringe that could have caused the leak, we cannot identify a definitive root cause at this time.H3 other text : see h10.

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe leaked past the stopper during use.The following information was provided by the initial reporter: "piston appears to be not tight during winding.When winding, liquid has leaked into the rear area of the syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 06-jan-2023.H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed.The product was further evaluated, no damaged was identified in the barrel or other components that could have caused a leak and the stopper was verified to be properly assembled onto the plunger rod.A device history review was performed for the reported lot 2105071, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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 leakage testing.The returned sample underwent the same tests and product met required specifications.Given that we did not observe any defect within the syringe that could have caused the leak, we cannot identify a definitive root cause at this time.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ 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.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15077035
• MDR Text Key: 296981536
• Report Number: 3003152976-2022-00327
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: 2105071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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