MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE NRFIT¿ LOK; PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT

Catalog Number	400174
Medical Device Problem Codes	Defective Component (2292); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe nrfit¿ lok had a molding defect.The following information was provided by the initial reporter translated from german to english: after visual inspection, every 2-3 syringes (5 pcs.On one strand) are affected by the production defect.See photos for details, the stamp is uneven.When did the incident occur? before use.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.The event / product problem was incorrect in the initial mdr.Correct event / product problem is mixed product / lots.Annex a code was incorrect in the initial mdr.Annex a code should be a2101 - device markings / labeling problem.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Twenty-eight samples and two photos were provided to our quality team for investigation.All 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.
Additional Manufacturer Narrative
Pr 10940619 follow up report for device evaluation.Post investigation findings revealed the additional failure of stopper jammed / insecure.Twenty-eight samples and two photos were provided to our quality team for investigation.All syringes were found with nrfit scale markings on a luer-lok barrel.Both photos show two syringes in unsealed packages, one syringe with the luer-lok barrel and one syringe having the stopper insecure to the plunger rod.The condition observed is non-conforming per product specification.Potential root cause for the stopper insecure defect is associated with the assembly process.These conditions are occurring below their expected frequency.Therefore, no corrective action is required at this time.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.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
Post investigation results indicate an additional failure of "stopper jammed / insecure".

• Brand Name: BD SYRINGE NRFIT¿ LOK
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20611934
• Report Number: 1213809-2024-00790
• Device Sequence Number: 7909484
• 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: GM
• 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,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 10/11/2024
• Supplement Date Received by Manufacturer: Not provided; 01/17/2025; 01/28/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/12/2024; 01/23/2025; 01/29/2025
• 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