MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC NEEDLE

Catalog Number	305145
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown. device manufacture date: unknown.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 a bd precisionglide¿ needle would not screw tightly on the hub which resulted in a medication spill.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
A photo sample was available for evaluation by bd.The photo was reviewed and it is not possible to identify the reported defect of leakage.The photo provided only showed the packaging and product details.It didn't provide any information regarding the actual needle or show evidence of a leakage.Based off of the information provided bd was unable to verify the reported failure mode.A review of the device history record could not be performed as a lot number was not available to bd.No determination of possible defect or root cause can be made from this photo.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7447114
• Report Number: 1911916-2018-00151
• Device Sequence Number: 13479277
• Product Code: FMI
• UDI-Device Identifier: 30382903051459
• UDI-Public: 30382903051459
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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 Catalogue Number: 305145
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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