MAUDE Adverse Event Report: BECTON DICKINSON (BD) 1CC SINGLE-USE INSULIN SYRINGE FOR U-100 INSULIN ; SYRINGE, PISTON

Lot Number 329416

Device Problem Detachment Of Device Component (1104)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/28/2018

Event Type  malfunction  

Event Description

Immediately after self-injection, i pulled the insulin syringe away from my body.Instead of the device remaining intact.The needle detached from the syringe and remained lodged in my skin.I was able to remove it.This type of needle detachment has happened about 10 times in the period of (b)(6) and (b)(6) 2018.There are two boxes of syringes involved.I've been diabetic for decades and never had this happen until now.

• Brand Name: 1CC SINGLE-USE INSULIN SYRINGE FOR U-100 INSULIN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON (BD)
• MDR Report Key: 7568834
• MDR Text Key: 110207736
• Report Number: MW5077634
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/01/2018
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 329416
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 105