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

Catalog Number	400067
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 blunt fill 18x1-1/2 nrfit ssu needle was clogged / blocked.The following information was provided by the initial reporter translated from french to english: we are writing to inform you of a materiovigilance report (internal sheet: 1901) dated 14/01/2025 regarding the following medical device: description: nrfit 18g 38mm sampling canula reference: 400067 lot: 4073912 expiry date: 31/03/2027 quantity concerned: 1 it was impossible to inject with this canula.The offending device is available at the pharmacy for examination.Please do not hesitate to contact us if you require any further information.Best regards, camille comte hospital pharmacy intern medical devices department logistics centre of the hôpitaux civils de colmar 8 rue de guebwiller 68000 colmar 03 89 12 49 75 additional information provided: has the patient or user suffered any harm? if yes, please explain no can you confirm whether samples are available for investigation? if yes, please specify if samples yes the needle in question used unused (before use) used (during or after use) important: if used, please confirm if samples are contaminated with blood or cytotoxic drugs.No.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
One sample was received by our quality team for evaluation.Upon inspection and testing, no blockage was observed.Fluid was able to flow through the needle.The reported incident could not be verified.A review of the internal manufacturing device records for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, no root cause could be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NDL 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: 21531997
• Report Number: 9614033-2025-00013
• Device Sequence Number: 15418169
• Product Code: GAA
• UDI-Device Identifier: 00382904000677
• UDI-Public: (01)00382904000677(11)240628(17)270331(10)4073912
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/30/2025

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 Catalogue Number: 400067
• Device Lot Number: 4073912
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown