MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® 10ML SYRINGE NRFIT¿ LOK (STERILE); PISTON SYRINGE WITH NEURAXIAL CONNECTOR

Model 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	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd® 10ml syringe nrfit¿ lok (sterile) the tip of the luer was deformed.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one of our testing sites initially believed the nrfit syringes to be incompatible with the nrfit needles; however upon closer inspection they confirmed the nrfit syringe contained a defect.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this.Initial reporter name and address: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd® 10ml syringe nrfit¿ lok (sterile) the tip of the luer was deformed.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: one of our testing sites initially believed the nrfit syringes to be incompatible with the nrfit needles; however upon closer inspection they confirmed the nrfit syringe contained a defect.
Additional Manufacturer Narrative
H6: investigation summary: one photo was provided to our quality team for investigation.Through visual inspection, it was observed that sample had 10ml luer lock standard barrel instead of 10ml nrfit lock barrel.Potential root cause for the mixed product defect is associated with inadequate line clearance on the marking machinery.A corrective action project was opened to further investigate these defect.Manufacturing personnel will be notified of this incident and additional training will be provided.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.Based on the investigation with the photo analysis the symptom reported is confirmed.
Additional Manufacturer Narrative
(b)(4).Follow up #2 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.

• Brand Name: BD® 10ML SYRINGE NRFIT¿ LOK (STERILE)
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR
• 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: 15498951
• Report Number: 1213809-2022-00649
• Device Sequence Number: 20294415
• Product Code: QEH
• UDI-Device Identifier: 00382904001742
• UDI-Public: (01)00382904001742(11)211111(17)260430(10)1041220
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192538
• 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,Followup
• Report Date (Section B): 11/12/2024

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 Expiration Date: 04/30/2026
• Device Model Number: 400174
• Device Catalogue Number: 400174
• Device Lot Number: 1041220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/12/2024
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/29/2022; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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