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

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 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 luer-lok¿ syringe experienced leakage.The following information was provided by the initial reporter, translated from french to english: when the nurse handled the syringe a viscous liquid came out at the piston/lot 2306743.

Manufacturer Narrative

One 50 ml syringe sample received for investigation.Through visual inspection, the stopper was correctly assembled to the plunger, no defects or issues observed.A device history review was performed for lot 2306743, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage test was performed, results are within specification, no leak observed.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.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.

Event Description

No additional information.

• Brand Name: BD 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17892430
• MDR Text Key: 325244784
• Report Number: 3003152976-2023-00441
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2306743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• 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