MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK 10ML SYRINGE 20 GAUGE X 1 INCH NEEDLE; PISTON SYRINGE

Model Number	309645
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok 10ml syringe 20 gauge x 1 inch needle experienced 2 missing labels.The following information was provided by the initial reporter: we have 2 bd products that are not labeled with an expiration.
Additional Manufacturer Narrative
Date of event: 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.Device expiration date: unknown.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following field was updated due to additional information: d.4.Medical device lot #: 9147373.D.4.Medical device expiration date: this batch expired in 2014 and we cannot confirm the exact date.H.4.Device manufacture date: this batch was manufactured in 2009 and we cannot confirm the exact date.H.6.Investigation summary: one packaged 10ml syringe with needle (p/n 309645) from lot 9147373 and two photos were received.The sample was visually evaluated with no visible defects noted.Based on the batch number 9147373 and the packaging graphics the syringe was manufactured in 2009.This batch was manufactured prior to the unique device identifier requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at that time.The syringe from batch 9147373 has been expired since 2014.Bd does not make claims of the efficacy of expired product.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.The dhrs for the products in this complaint are not available for review as records are only maintained for seven years.
Event or Problem Description
It was reported that the bd luer-lok 10ml syringe 20 gauge x 1 inch needle experienced 2 missing labels.The following information was provided by the initial reporter: we have 2 bd products that are not labeled with an expiration.

• Brand Name: BD LUER-LOK 10ML SYRINGE 20 GAUGE X 1 INCH NEEDLE
• Common Device Name: 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: 14714514
• Report Number: 1213809-2022-00336
• Device Sequence Number: 2202159
• Product Code: FMF
• UDI-Device Identifier: 30382903096450
• UDI-Public: 30382903096450
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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
• Operator of Device: Other
• Device Model Number: 309645
• Device Catalogue Number: 309645
• Device Lot Number: 9147373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown