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

Catalog Number 329515

Device Problem Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd autoshield¿ duo pen needle leaked insulin onto the consumer during the injection, resulting in elevated glucose levels.The following information was provided by the initial reporter: "adult daughter of consumer reported finding when using the autoshield duo on her dad, the insulin is not going into his skin.Insulin rest on the top of skin.Caller was not informed of the features of the duo pen needle.Informed caller when she was at their local walgreens pharmacy how to use the item.--- caller reported dads glucose values are elevated to 463.Lot # unknown at this time.Date of event (b)(6) 2023".

Event Description

It was reported that the bd autoshield¿ duo pen needle leaked insulin onto the consumer during the injection, resulting in elevated glucose levels.The following information was provided by the initial reporter: "adult daughter of consumer reported finding when using the autoshield duo on her dad, the insulin is not going into his skin.Insulin rest on the top of skin.Caller was not informed of the features of the duo pen needle.Informed caller when she was at their local walgreens pharmacy how to use the item.Caller reported dads glucose values are elevated to 463.

Manufacturer Narrative

H.6.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD AUTOSHIELD¿ DUO PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17981487
• MDR Text Key: 326282258
• Report Number: 9616656-2023-01130
• 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: K223286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 329515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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