MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE ADMIX NOKOR 18X1-1/2 TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305215
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ needle admix nokor 18x1-1/2 tw had an insect inside the needle.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
One photo was provided for evaluation.It shows a needle assembly with an insect- ant- inside the plastic shield, therefore failure mode is verified.The pest control records were verified finding no pest ¿ant- activity in this production area.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that bd¿ needle admix nokor 18x1-1/2 tw had an insect inside the needle.No serious injury or medical intervention was reported.

• Brand Name: BD¿ NEEDLE ADMIX NOKOR 18X1-1/2 TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8299039
• Report Number: 1911916-2019-00139
• Device Sequence Number: 18845404
• Product Code: FMI
• UDI-Device Identifier: 30382903052159
• UDI-Public: 30382903052159
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 305215
• Device Lot Number: 7291806
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other