MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLES TW

Catalog Number	305186
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(b)(6).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 bd¿ needles tw had white debris on them.The following information was provided by the initial reporter: ¿we are still seeing issues with our bd needles coming to us with white debris on them.Even though last time, we were told that this is not a widespread issue, we are still seeing the issue.¿.
Event or Problem Description
It was reported that bd¿ needles tw had white debris on them.The following information was provided by the initial reporter: ¿ we are still seeing issues with our bd needles coming to us with white debris on them.Even though last time, we were told that this is not a widespread issue, we are still seeing the issue.¿.
Additional Manufacturer Narrative
Investigation: two (2) photos were provided by the customer for investigation by our quality tea.One (1) photo shows a packaged needle and shield in the blister pack showing the batch number.The second photo shows a needle hub attached to a syringe with the needle shield removed.The second photo appears to show a piece of white foreign matter (fm) on the needle.A device history record (dhr) review was performed on the batch associated with this investigation (batch 8172881).The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Based on the photographs provided the quality team can confirm the presence of white foreign matter (fm) on the needle.However, without a physical sample to analyze the fm on the needle cannot be identified; therefore, potential root causes cannot be determined nor can the size of the fm be determined.

• Brand Name: BD¿ NEEDLES TW
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8476041
• Report Number: 1911916-2019-00344
• Device Sequence Number: 1955518
• Product Code: FMI
• UDI-Device Identifier: 30382903051862
• UDI-Public: 30382903051862
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 08/31/2023
• Device Catalogue Number: 305186
• Device Lot Number: 8172881
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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