MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE VENTED NOKOR 16X1; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305213
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
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material #:305213 batch#: 3158878 it was reported by customer that black particles found.Pt harm: no samples: yes additional information: date of event: 3/22/24 ¿ please confirm whether there was any patient impact.No patient impact reported ¿ any physical sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? return label has been shipped and samples are on the way.¿ any picture of this complaint? no picture.
Additional Manufacturer Narrative
(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 305213 and lot number 3158878.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received material #:305213 batch#: 3158878.It was reported by customer that black particles found.Verbatim: complaint received.Productcomplaint-mds.Facility: (b)(6) med.Address: (b)(6).Contact: (b)(6).Email: (b)(6).Phone: (b)(6).Contact: (b)(6).Email: (b)(6).Phone: (b)(6).Issue: black particles found.Ref 305213, lot 3158878.Pt harm: no, samples: yes , please cc purchasing dept as well in all communication.

• Brand Name: NEEDLE VENTED NOKOR 16X1
• 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: 19058441
• Report Number: 1911916-2024-00242
• Device Sequence Number: 6593338
• Product Code: GAA
• UDI-Device Identifier: 00382903052134
• UDI-Public: (01)00382903052134
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 305213
• Device Lot Number: 3158878
• 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: 05/06/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown