MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	309578
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd luer-lok¿ syringe with precisionglide¿ needle there was an issue with scale marking error.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: ten sealed 3ml packaged syringes with needle were received and confirmed to be from batch #8155886 (p/n 309578).The samples were visually evaluated.All ten syringes have more than 50% of the print missing.The entire scale is affected with the majority of the lower scale missing.The missing print observed is rejectable per product specification.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the print defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.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.
Event or Problem Description
It was reported with the use of the bd luer-lok¿ syringe with precisionglide¿ needle there was an issue with scale marking error.There was no report of injury or medical intervention.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7903477
• Report Number: 1213809-2018-00624
• Device Sequence Number: 19238716
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 309578
• Device Lot Number: 8155886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other