MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE 20 G X 1 1/2 IN; HYPODERMIC NEEDLE

Catalog Number	305179
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
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 before use that several bd precisionglide¿ needle 20 g x 1 1/2 in, the needle length was not accurate.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: ten photos were attached.Six of the photos were of packaging materials, and packaged needles.The remaining four photos show one needle with angularity therefore failure mode is verified.The specification for cannula angularity is 2 ½ degrees off the centerline of the hub.The root cause could be the hub id is defective, or the cannula may be bowed.Root cause cannot be determined based on the photos provided.This appears to be an isolated incident.No corrective action will be initiated at this time.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.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 before use that several bd precisionglide¿ needle 20 g x 1 1/2 in, the needle length was not accurate.There was no report of injury or medical intervention.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE 20 G X 1 1/2 IN
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7874036
• Report Number: 1911916-2018-00504
• Device Sequence Number: 13972151
• Product Code: FMI
• UDI-Device Identifier: 30382903051794
• UDI-Public: 30382903051794
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 06/30/2022
• Device Catalogue Number: 305179
• Device Lot Number: 7139542
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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