MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE NRFIT¿ LOK; NEURAXIAL SYRINGE

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	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported the bd syringe nrfit¿ lok with mixed product/lots.The following information was provided by the initial reporter: this lots of reference are mixed syringes nrfit with syringes luerlock,.All within the same box with the same reference (nrfit) and the same assembly.
Additional Manufacturer Narrative
One hundred and ninety-five samples and one photo of 10ml nrfit syringes were received by bd.A quality engineer was able to examine the samples and photo from batch 1041220 regarding item 400174.All samples were received in sealed packages with all applicable product information on the package, and the samples were all found to be acceptable with no defects observed; however, the photo showed two sealed syringes next to each other with one being a standard luer-lok syringe tip and the other being an nrfit barrel tip.The observed mixed product condition was non-conforming per product specification.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 this defect.Manufacturing personnel will be notified of this incident and additional training will be provided.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE NRFIT¿ LOK
• Common Device Name: NEURAXIAL SYRINGE
• 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: 19346824
• Report Number: 1213809-2024-00296
• Device Sequence Number: 2685843
• 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: SP
• 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): 11/05/2024

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 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: 04/26/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown