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 Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the non-patient end shield fell off the bd autoshield¿ duo safety pen needle experienced leakage during use.The following information was provided by the initial reporter: during administration of the prescribed dose of insulin, the patient reports that he did not feel the injection.Upon checking the syringe it is found that the insulin dose was inside the protective cap.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: b5: describe event or problem: ¿the cap had been removed.The needle used in this case, used together with the insulin pen, has a safety system that makes sure that the needle comes out of the protection when it is squeezed to administer and then re-enters the safety shield so that the personnel do not accidentally prick themselves.The system did not work, the needle did not come out, it did not prick the arm of the patient and when i pressed it, the insulin remained inside the protective plastic".H.2.If follow-up, what type: additional information.
Event or Problem Description
It was reported that the non-patient end shield fell off the bd autoshield¿ duo safety pen needle experienced leakage during use.The following information was provided by the initial reporter: during administration of the prescribed dose of insulin, the patient reports that he did not feel the injection.Upon checking the syringe it is found that the insulin dose was inside the protective cap.Additional information: ¿the cap had been removed.The needle used in this case, used together with the insulin pen, has a safety system that makes sure that the needle comes out of the protection when it is squeezed to administer and then re-enters the safety shield so that the personnel do not accidentally prick themselves.The system did not work, the needle did not come out, it did not prick the arm of the patient and when i pressed it, the insulin remained inside the protective plastic".
Event or Problem Description
It was reported that the non-patient end shield fell off the bd autoshield¿ duo safety pen needle experienced leakage during use.The following information was provided by the initial reporter: during administration of the prescribed dose of insulin, the patient reports that he did not feel the injection.Upon checking the syringe it is found that the insulin dose was inside the protective cap.
Additional Manufacturer Narrative
H.6.Investigation summary no samples or photos were returned for analysis.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 as per the applicable operations and met qc specification.

• 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: 10241946
• Report Number: 9616656-2020-00639
• Device Sequence Number: 2624278
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 329605
• Device Lot Number: 0049412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 06/16/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/15/2020; 10/07/2020
• 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