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

Catalog Number	305214
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material# 305214, batch# unknown.It was reported by customer that they are having issues with the needle coring out the vial stopper.Verbatim: rcc received a complaint via email.Email(s) attached.Requesting if we have recommendations for a customer that is having issues using the nokor vented needle (ref 305214).They are having issues with the needle coring out the vial stopper.They have to then place another needle to filter out the material.Also, has questions on how the nokor vented needles work.
Additional Manufacturer Narrative
Pr 10101147 follow up.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.H3 other text : see h10 narrative.
Event or Problem Description
No additional information received material# 305214 batch# unknown it was reported by customer that they are having issues with the needle coring out the vial stopper.Verbatim: rcc received a complaint via email.Email(s) attached.Requesting if we have recommendations for a customer that is having issues using the nokor vented needle (ref 305214).They are having issues with the needle coring out the vial stopper.They have to then place another needle to filter out the material.Also, has questions on how the nokor vented needles work.

• Brand Name: NEEDLE VENTED NOKOR 18X1
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19285354
• Report Number: 1911916-2024-00342
• Device Sequence Number: 7620078
• Product Code: GAA
• UDI-Device Identifier: 00382903052141
• UDI-Public: (01)00382903052141
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown