MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE VENTED NOKOR 18X1 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305214
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 305214 batch#: 3173341 it was reported by the customer that the nokor non-coring vented needle is classified as a blunt fill needle.Verbatim: rcc received a complaint via email.Email(s) attached.Question caller states they use the nokor non-coring vented needle 305214.Caller was asking if there are anyinstructions for how to use the nokor needles.Caller states they recently purchased these to help eliminatecoring in their vials.They used the nokor needle this morning and ended up having coring in a third of theirvials leading to stopper material in the vials.Caller provided the lot number 3173341.Caller also asking for acopy of the coa.Response informed caller the nokor non-coring vented needle is classified as a blunt fill needle.Product code 305214is vented, meaning it has a side port to help vent and reduce vial pressure.Emailed the blunt fill usageguidelines for reference.Informed caller i will submit this to our product complaints team for furtherinvestigation.Informed caller the coa can be located on the bd regulatory site product/modelnumber: 305214.
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0202 - defective component.Patient problem code: f27 ¿ no patient involvement.
Event or Problem Description
No additional information received.Materials#: 305214, batch#: 317334.1 it was reported by the customer that the nokor non-coring vented needle is classified as a blunt fill needle.Verbatim: rcc received a complaint via email.Email(s) attached.Question: caller states they use the nokor non-coring vented needle 305214.Caller was asking if there are anyinstructions for how to use the nokor needles.Caller states they recently purchased these to help eliminatecoring in their vials.They used the nokor needle this morning and ended up having coring in a third of theirvials leading to stopper material in the vials.Caller provided the lot number 3173341.Caller also asking for acopy of the coa.Response: informed caller the nokor non-coring vented needle is classified as a blunt fill needle.Product code 305214is vented, meaning it has a side port to help vent and reduce vial pressure.Emailed the blunt fill usageguidelines for reference.Informed caller i will submit this to our product complaints team for furtherinvestigation.Informed caller the coa can be located on the bd regulatory site.Product/modelnumber: 305214.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported the needle was causing coring in vials.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for investigation by our quality team.The photo shows the magnification of a nokor needle tip.No defects or imperfections were observed.A device history record review was completed for provided material number 305214, lot 3173341.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

• Brand Name: NEEDLE VENTED NOKOR 18X1 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18282611
• Report Number: 1911916-2023-00876
• Device Sequence Number: 12272884
• Product Code: GAA
• UDI-Device Identifier: 00382903052141
• UDI-Public: (01)00382903052141
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: Health Professional
• Device Catalogue Number: 305214
• Device Lot Number: 3173341
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown