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

Catalog Number	329605
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 autoshield¿ duo safety pen needle leaked medication onto the consumer's skin after use.The pen was reportedly removed from the refrigerator "10 minutes" before application, and the application button was held for "10 seconds" before removing.The following information was provided by the initial reporter, translated from (b)(6) to english: claimant reported that from the first day of use, he noticed that there was a leak.She said she was using the bd autoshield duo needle, which is supplied in the kit, but that when she switched to a needle she already had at home (bd ultrafine 4mm x.23mm, there were no more leaks.Still, she said she the take out the pen of the refrigerator, about 10 minutes before applying, cleanse, place the needle, remove the protective cap, adjust the dose, position on the skin, press the application button, hold for 10 seconds and remove from the skin.Said she has medicine on the skin, well more than a drop.
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.
Event or Problem Description
It was reported that the bd autoshield¿ duo safety pen needle leaked medication onto the consumer's skin after use.The pen was reportedly removed from the refrigerator "10 minutes" before application, and the application button was held for "10 seconds" before removing.The following information was provided by the initial reporter, translated from portuguese to english: claimant reported that from the first day of use, he noticed that there was a leak.She said she was using the bd autoshield duo needle, which is supplied in the kit, but that when she switched to a needle she already had at home (bd ultrafine 4mm x.23mm, there were no more leaks.Still, she said she the take out the pen of the refrigerator, about 10 minutes before applying, cleanse, place the needle, remove the protective cap, adjust the dose, position on the skin, press the application button, hold for 10 seconds and remove from the skin.Said she has medicine on the skin, well more than a drop.

• Brand Name: BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8794745
• Report Number: 9616656-2019-00631
• Device Sequence Number: 11483797
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 329605
• Device Lot Number: 8138966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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