MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP; CONVENTIONAL SYRINGE

Catalog Number 309657

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was found with difficult plunger movement as ¿customer reports that after filling her syringe with insulin, she was not able to push on the plunger to release the insulin.Customer couldn't get the insulin out of syringe.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.No root cause can be determined as no samples were received.Based on the fact that no defect was found, capa is not required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7359402
• MDR Text Key: 103357297
• Report Number: 1213809-2018-00189
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other