MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE, SUB-Q; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305115
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the bd precisionglide¿ needle, sub-q pierced through the cap and resulted in a contaminated needle stick.The doctor and patient were reported to have been tested for "any communicable diseases and are negative so far".
Event or Problem Description
It was reported that the bd precisionglide needle, sub-q pierced through the cap and resulted in a contaminated needle stick.The doctor and patient were reported to have been tested for "any communicable diseases and are negative so far".
Additional Manufacturer Narrative
Two unopened needles were returned for evaluation.The returned samples are not bent, and are not protruding through the shield.The photo sample shows a bent needle protruding through the shield.The bent needle was caused when it struck bone during an injection.The needle stick occurred when the end user attempted to re-shield the bent needle.The point of the bent needle caught the wall of the shield, and penetrated it.It is recommended to follow cdc guidelines and not reshield used needles.Discard unshielded needles into a sharps container.If this is not possible, use a one handed, passive recapping technique, to cover the needle.Ensure that the needle shield is properly seated on the hub.Do not force the shield onto the needle, as the needle may penetrate the shield causing injury.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.Assembly batch 7059639 had ten visual inspections performed on 650 parts with zero defect or issues noted.No quality notifications were written for this batch, nor for the associated assembly.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE, SUB-Q
• 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: 8019303
• Report Number: 1911916-2018-00599
• Device Sequence Number: 13791242
• Product Code: FMI
• UDI-Device Identifier: 30382903051152
• UDI-Public: 30382903051152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 305115
• Device Lot Number: 7058607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: Required Intervention