MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO PEN NEEDLE

Catalog Number	329515
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd autoshield¿ duo pen needle safety shield failed and nurse was stuck by a clean needle.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: customer returned (1) open 5mm, 30g autoshield duo sample from lot # 8138959.Customer states that a nurse was stuck by clean needle when safety cap fell off the bd autoshield duo pen needle and when the needle was re-sheathed in needle holder, the orange shield inside mechanism fell out of needle holder.The autoshield duo sample was returned with the non patient cannula shield separated from the rest of the pen needle, exposing the non patient end of the cannula.Since this end of the safety pen needle was exposed, a needle stick could occur.Capa 478527 has been opened to address this issue.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.
Event or Problem Description
It was reported that bd autoshield¿ duo pen needle safety shield failed and nurse was stuck by a clean needle.No serious injury or medical intervention was reported.

• Brand Name: BD AUTOSHIELD¿ DUO PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8203784
• Report Number: 9616656-2018-00375
• Device Sequence Number: 2640966
• Product Code: FMI
• UDI-Device Identifier: 00382903295159
• UDI-Public: 00382903295159
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110007
• 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): 01/29/2019

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: 06/30/2021
• Device Catalogue Number: 329515
• Device Lot Number: 8138959
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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