MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY; HYPODERMIC NEEDLE

Catalog Number	305156
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that before use a bd¿ hypodermic precisionglide¿ needle without safety was found with a sterile barrier breach as ¿the top of injection packaging broke.¿ there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
No sample or photo was available for evaluation by bd.Therefore, a quality engineer was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed.Bd was unable to determine any corrective actions or root cause for the reported problem of broken packaging.A device history review was performed.Thirty-one visual inspections were performed on 1,860 parts on the reported lot and found zero defects recorded during production.Qn review: no notifications were written for this batch.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7354017
• Report Number: 1911916-2018-00119
• Device Sequence Number: 1740649
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 12/31/2021
• Device Catalogue Number: 305156
• Device Lot Number: 6339816
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/23/2018
• 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