MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE 27GA 1-1/2IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	301629
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Initial reporter: address unavailable.Bd corporate address used.Fda notified?: the initial reporter also notified the fda on (date) via medwatch # 5083620.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd precisionglide¿ needle 27ga 1-1/2in that a white substance was found on the needle hub.
Event or Problem Description
It was reported that before use of the bd precisionglide¿ needle 27ga 1-1/2in that a white substance was found on the needle hub.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 1st complaint for the lot# 7289732 for the same defects or symptoms.There was no documentation of issues for the complaint of batch #7289732 during this production run.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE 27GA 1-1/2IN
• 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: 8403755
• Report Number: 1911916-2019-00252
• Device Sequence Number: 269047
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: 30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 301629
• Device Lot Number: 7289732
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/18/2019
• 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