MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR ADMIX NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305216
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	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.
Additional Manufacturer Narrative
Correction: after further review, it was found that this report is a duplicate of mfr# 1911916-2021-01302.This complaint will be cancelled.
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.

• Brand Name: BD NOKOR ADMIX NEEDLE
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13101456
• Report Number: 1911916-2021-01301
• Device Sequence Number: 19954398
• Product Code: GAA
• UDI-Device Identifier: 00382903052165
• UDI-Public: 00382903052165
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 01/31/2025
• Device Model Number: 305216
• Device Catalogue Number: 300780
• Device Lot Number: 9322474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown