MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE 18 G X 1 1/2 IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305199
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
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 that foreign matter was found on a bd precisionglide¿ needle 18 g x 1 1/2 in.The product was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation: one sample was returned.There is black fm in the id of the hub.Dhr review revealed no irregularities during the manufacture of the reported lot number.Possible root cause is a dirty pin on the assembly rack.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE 18 G X 1 1/2 IN
• 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: 6994914
• Report Number: 1911916-2017-00285
• Device Sequence Number: 11058710
• Product Code: FMI
• UDI-Device Identifier: 30382903051992
• UDI-Public: 30382903051992
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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: 305199
• Device Lot Number: 7114808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/01/2017
• 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