MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE

Catalog Number	309629
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on (date) via medwatch # (b)(4).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 by the nurse that the bd luer-lok¿ syringe has tick marks then starts at 10 units.Found before use.No serious injury or medical intervention noted.
Additional Manufacturer Narrative
A single 1ml luer-lok u-100 insulin received for p/n 309629 without package.The sample was visually evaluated and no print defects were observed.Product defect was not confirmed based on sample evaluation performed.A device history record review was performed and showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Manufacturing dates for batch 7058861: (b)(6) 2017-(b)(6) 2017, batch size was 300,000 pieces.No quality notifications were created during the production of complaint batch.Batch 7058861 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Root cause undetermined since no product defects were confirmed.Capa not required based on severity and occurrence level defined for this complaint.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¿ SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7275309
• Report Number: 1213809-2018-00044
• Device Sequence Number: 2379151
• Product Code: FMF
• UDI-Device Identifier: 00382903096299
• UDI-Public: 00382903096299
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: Nurse
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 309629
• Device Lot Number: 7058861
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/19/2018
• 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