MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR¿ FILTER AND ADMIX NEEDLES; NEEDLE VENTED NOKOR 18X1 TW NEEDLE

Catalog Number	305214
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 four of the bd nokor¿ filter and admix needles experienced compromised sterility from foreign matter.
Event or Problem Description
It was reported that four of the bd nokor¿ filter and admix needles experienced compromised sterility from foreign matter.
Additional Manufacturer Narrative
Investigation summary: two photos were provided for evaluation.One photo shows the packaging top web and the other photo shows the needle assembly with a hair that got trapped between the top and bottom webs, therefore failure mode is verified.Operator interaction with the product is minimal, however, hair contamination is possible if proper gowning is not followed.All operators are trained to a gowning procedure to minimize risk of hair contamination.Per procedure, hairnets/beard covers must always be put on before the smock.The hairnet and beard cover must cover all hair.Hairnets and beard covers must be discarded once removed.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.

• Brand Name: BD NOKOR¿ FILTER AND ADMIX NEEDLES
• Common Device Name: NEEDLE VENTED NOKOR 18X1 TW NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8240993
• Report Number: 1911916-2018-00819
• Device Sequence Number: 2462826
• Product Code: FMI
• UDI-Device Identifier: 00382903052141
• UDI-Public: 00382903052141
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 02/28/2022
• Device Catalogue Number: 305214
• Device Lot Number: 6363747
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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