MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD NDL FILTER BLUNT FILL 18X1-1/2 NRFIT SSU; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	400066
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2025
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 that the bd ndl filter blunt fill 18x1-1/2 nrfit ssu had a syringe needle connectivity issue.The following information was provided by the initial reporter: theatres are experiencing an issue with one of the new nrfit drawing up 5 micron filter needles, where the nrfit connector comes away from the needle.Appears the nrfit part is glued to the original luer connector to make it nrfit compliant.It is possible to snap off the nrfit section and use it on other luer needles.
Additional Manufacturer Narrative
Investigation results: the claim is classified as unconfirmed since the customer does not provide physical samples or photographs to carry out the corresponding analysis.However, according to the trend analysis, the previously reported defect already has an action plan for defect mitigation.
Event or Problem Description
No additional information.

• Brand Name: BD NDL FILTER BLUNT FILL 18X1-1/2 NRFIT SSU
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23375184
• Report Number: 9614033-2025-00108
• Device Sequence Number: 8915967
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660(11)231025(17)260228(10)3054754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: Other
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 400066
• Device Lot Number: 3054754
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown