MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD BLUNT FILTER NRFIT; NEEDLE

Catalog Number	400067
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos received by our quality team for investigation.Through visual inspection, non-bd syringe with liquid is observed with a black foreign matter, a foreign matter analysis is attached, and a bd blunt fill needle.The client mentions that the white epoxy which the needle adheres to the adapter coincides with the results of the analysis of the foreign matter found in the syringe.A device history review was performed for the reported lot 3045503 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The contamination in the syringe could not be generated by the adhesive used in the needle assembly process.Additionally, the foreign matter observed by the customer is black, the epoxy adhesive is white.Physical samples are required to further analyze.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.
Event or Problem Description
It was reported that the bd blunt filter nrfit had foreign matter.The following information was provided by the initial reporter: particle was visually encountered in the syringe and image taken with microscopy.Ft-ir results can be seen.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD BLUNT FILTER NRFIT
• Common Device Name: NEEDLE
• 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: 19101574
• Report Number: 9614033-2024-00038
• Device Sequence Number: 17977887
• Product Code: GAA
• UDI-Device Identifier: 00382904000677
• UDI-Public: (01)00382904000677
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 01/31/2026
• Device Catalogue Number: 400067
• Device Lot Number: 3045503
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown