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

Catalog Number 300865

Device Problem Leak/Splash (1354)

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

Event Date 08/27/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd plastipak¿ concentric luer lock syringes leaked past their plunger stoppers, one while being filled with propofol, the other while propofol was being infused.The following information was provided by the initial reporter, translated from french: "both syringes failed to seal the elastomeric plunger seal, one when the syringe was being filled with propofol and the other when the propofol was being infused by pse (electric syringe pump) description of incidents: two incidents on the same day with the same lot: sealing problem at the joint.Elastomer of the piston when filling the syringe with propofol: propofol in the joint.Syringe not administered.Sealing problem at the joint.Elastomer of the piston during infusion of the propofol through the pse: flow of propofol on along the piston, puddle of propofol on the floor, air bubbles in the tubing.The ide noticed it before there was damage to the patient.Timeline (24-hour pse): 12:00 p.M.: connection, 3:00 p.M.: no anomaly, 6:00 p.M.: the ide notes the leak and air bubbles in the tubing.".

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 2 bd plastipak¿ concentric luer lock syringes leaked past their plunger stoppers, one while being filled with propofol, the other while propofol was being infused.The following information was provided by the initial reporter, translated from french: "both syringes failed to seal the elastomeric plunger seal, one when the syringe was being filled with propofol and the other when the propofol was being infused by pse (electric syringe pump) description of incidents: two incidents on the same day with the same lot: 1/ sealing problem at the joint elastomer of the piston when filling the syringe with propofol: propofol in the joint.Syringe not administered.2/ sealing problem at the joint elastomer of the piston during infusion of the propofol through the pse: flow of propofol on along the piston, puddle of propofol on the floor, air bubbles in the tubing.The ide noticed it before there was damage to the patient.Timeline (24-hour pse): 12:00 p.M.: connection.3:00 p.M.: no anomaly.6:00 p.M.: the ide notes the leak and air bubbles in the tubing.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-sep-2022.H6: investigation summary one sample was provided to our quality team for investigation.Though visual inspection, a leakage past the stopper ribs was observed.It was noted the barrel was damaged, causing the stopper to become distorted against the barrel wall when moved across that point and resulting in the leakage that was reported.A device history review was performed for the reported lot 2206097, 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.While we could not identify a direct issue, it was determined the damage likely occurred during the assembly process.

• 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
• 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: 15481581
• MDR Text Key: 306418572
• Report Number: 3003152976-2022-00442
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2206097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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