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 Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe nrfit¿ lok had mixed product / lots.The following information was provided by the initial reporter: we have had an issue discovered by 2 sites when using nrfit syringes and drawing up needle for spinal.The syringe was not compatible with the needle but could be connected to ordinary iv cannula.This is affecting batch (b)(4) with the lot number 1041220 can you please advise dean and i if the supplier will be replacing or crediting us for the (b)(4) ea he has moved into quarantine last week, and what we need to do with their quarantined stock? additional information provided: customer response received information requested is below; company: spire healthcare national distribution centre collection point: goods in/out street, number: (b)(6) building, floor: ndc postal code: (b)(6).Country: uk please also provide us with the phone number of a person who can be contacted by the carrier.Contact name: (b)(6).Phone number: (b)(6) e-mail address: ndcstockcontrolteam@spirehealthcare.Com.
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.
Additional Manufacturer Narrative
(b)(6): supplemental mdr - mixed product / lots.Six hundred and ninety-five samples were provided to our quality team for investigation.Six hundred samples were found with no defects and ninety-five 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.
Event or Problem Description
No additional information was provided.

• 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: 21023405
• Report Number: 1213809-2024-00996
• Device Sequence Number: 8367236
• 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: Nurse Practitioner
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/24/2025
• 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