MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML L/T SSU NRFIT WWS; PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT

Catalog Number	400174
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description details: before use: there is a fault with the 10ml syringe nrfit lok lot 1041220 ref (b)(4).Within the batch there are normal luer lock syringes mixed in with the nrfit syringes.No patient harm.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Eighty-one samples were provided to our quality team for investigation.Seventy-five samples were found with no defects and six syringes were found with nrfit scale markings on a luer-lok barrel.The condition observed is non-conforming per product specification.Potential root causes for the mixed product defect could be associated with failure to properly contain any previously conveyed product prior to the nrfit run and inadequate line clearance on the marking machinery.Situation analysis and corrective and preventative actions were initiated with multiple corrective actions identified and implemented.Additionally, a corrective action opened under internal exception was to better control the process related to conveyed raw materials.These changes will be documented in updates to the process control forms and applicable work instructions.Operators and supervisors signed off to the machinery and line clearance documentation were re-educated to the documentation via internal system.Furthermore, a device history record review was completed for provided lot number 1041220.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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: SYRINGE 10ML L/T SSU NRFIT WWS
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20997689
• Report Number: 1213809-2024-00986
• Device Sequence Number: 13221457
• Product Code: QEH
• UDI-Device Identifier: 00382904001742
• UDI-Public: (01)00382904001742(11)211111(17)260430(10)1041220
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 400174
• Device Lot Number: 1041220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/22/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown