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

Catalog Number	400066
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd blunt filter nrfit connector disconnected from the needle hub.The following information was provided by the initial reporter translated from french to english: during a discussion this morning with novartis, they have informed me that they encountered a problem with their nrfit filter needle sku 400066.During the lab testing in order to create ifu for spinal injection, they have encountered a 1 out of 60 fails where the nrfit disconnected from the filter at the point where it is glued on.They should be sending additional information soon, but i am still sharing the information i have received today.You should be receiving info from (b)(6).Additional information provided.The disentangle of the nrfit connector from the needle hub occurred when the operator was trying to remove normally the red needle shield from the needle.
Additional Manufacturer Narrative
Photo received by our quality team for investigation.Through visual inspection, a case assembled to the filter, but separated from the adapter is observed.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Possible root cause is associated with incorrect adhesive application.Manufacturing personnel have been notified of this incident to increase awareness of this matter.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Photo received by our quality team for investigation.Through visual inspection, a case assembled to the filter but separated from the adapter is observed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is associated with manual adhesive placement.Manufacturing personnel have been notified of this incident to increase awareness of this matter.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.
Event or Problem Description
Batch number 3347387 was provided.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.The batch number was incorrect in the initial mdr, batch number is 3347387.

• 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: 20334325
• Report Number: 9614033-2024-00062
• Device Sequence Number: 8136101
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660(11)240229(17)261231(10)3347387
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/12/2024

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 Catalogue Number: 400066
• Device Lot Number: 3347387
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/14/2024; Not provided; 12/12/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/12/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown