MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM

Model Number 329515

Device Problems Leak/Splash (1354); Misconnection (1399)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 01/12/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.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 investigation conclusion: unconfirmed: bd was not 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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd autoshield duo pen needle 30ga 5mm did not deliver insulin to the patient.: the following information was provided by the initial reporter: verbatim: two events were observed wherein trained nurses attempted to administer insulin using this safety needle (with an insulin pen).Despite proper technique and appropriate delay in removing needle after delivering dose, the entire dose of insulin was not delivered to the patient and was observed dripping down skin.Both cases resulted in hyperglycemia and the need for additional insulin.In addition, after raising the issue, several more nurses have reported finding that the insulin is sluggish to administer and several cases where the needle was bent.A nurse and an endocrinologist witnessed the most recent failure for a patient.Despite proper technique, when the pen/needle was removed from the patient, insulin was seen dripping on the patient¿s skin, the patient reported not feeling the injection, and the subsequent blood sugar was elevated (400).A similar report was provided from the picu.Upon questioning of staff in several patient care areas, we have heard reports of bent needles and other difficulties (pen sent back to pharmacy because of injection problems that may have been the needle, rather than the pen in hindsight).The design of this safety needle makes it very difficult for nurses to determine when the needle has adequately entered the skin for the injection.

• Brand Name: BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9678538
• MDR Text Key: 178106572
• Report Number: 9616656-2020-00091
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903295159
• UDI-Public: 00382903295159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 329515
• Device Catalogue Number: 329515
• Device Lot Number: 9231933
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other