MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML; PISTON SYRINGE

Model Number 309646

Device Problem Complete Blockage (1094)

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

Event Date 01/11/2023

Event Type  malfunction  

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 luer-lok¿ syringe sterile, single use, 5 ml the plunger movement was difficult.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: this melting/defect has been seen to cause issues so far with pushing liquid from syringe.2 reported and one instance they drew blood on the patient was not able to place in in the tubes to send down to the lab after drawing from patient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 17-feb-2023.H6: investigation summary: one sample and one photo were provided to our quality team for investigation.Through visual inspection, it was observed that the barrel has damaged at 1ml graduation line.Potential root cause for the barrel damaged defect is associated with the assembly process.A device history record review was completed for provided lot number 2304432.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

Event Description

It was reported while using bd luer-lok¿ syringe sterile, single use, 5 ml the plunger movement was difficult.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: this melting/defect has been seen to cause issues so far with pushing liquid from syringe.2 reported and one instance they drew blood on the patient was not able to place in in the tubes to send down to the lab after drawing from patient.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301886
• MDR Text Key: 308866477
• Report Number: 1213809-2023-00060
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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 Model Number: 309646
• Device Catalogue Number: 309646
• Device Lot Number: 2304432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/04/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1