MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD BLUNT FILTER NRFIT; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	400066
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 bd ndl filter blunt fill 18x1-1/2 nrfit ssu label content was incorrect.We have noticed that a batch received in december 2025 has an expiry date earlier than that of a similar batch received in november 2024.Receipt on 05/12/2025 of canulas ref (b)(4), bd 400066 batch: 2512100229, which expires in august 2026.Thank you for your feedback, the corresponding quantity is (b)(4) needles.
Additional Manufacturer Narrative
(b)(4) follow up report for correction for date of event.
Event or Problem Description
Event date verified with customer.

• Brand Name: BD BLUNT FILTER NRFIT
• 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: 24519870
• Report Number: 9614033-2026-00019
• Device Sequence Number: 12890454
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660(11)231221(17)260831(10)3237972
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/26/2026

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: 08/31/2026
• Device Catalogue Number: 400066
• Device Lot Number: 3237972
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 05/26/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/13/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown