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

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown.The date received by manufacturer has been used for this field.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¿ concentric luer lock syringe leaked from the back piston.The following information was provided by the initial reporter: "setting up a propofol aivoc mode anaesthesia, leakage of the syringe at the back on the piston side syringe change".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: 7/21/2021.H.6.Investigation: one used sample was received for evaluation by our quality engineer.Through visual inspection of the sample, a leakage between the stopper ribs was observed.The product was disassembled for further inspection, there was no damage noted in the plunger rod that could have caused a leak and the stopper was verified to be properly assembled, however, it was noted there was damage on the barrel which can prevent a proper seal when the stopper moves across this point, resulting in the leak observed.A device history review was performed for the reported lot 2012082, 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 these tests and product was verified to meet required specifications.Root cause could not be determined.

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe leaked from the back piston.The following information was provided by the initial reporter: "setting up a propofol aivoc mode anaesthesia leakage of the syringe at the back on the piston side syringe change".

• Brand Name: BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12281862
• MDR Text Key: 265201602
• Report Number: 3003152976-2021-00452
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2012082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1