MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number 305270

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 needle of the bd integra¿ syringe with detachable needle "blew off" the syringe right before the injection, spilling out depo testosterone.The following information was provided by the initial reporter: "i set up an injection that is inter muscular injection, that i have been doing once a week for 15 years.I loaded the bd integra syringe with ____ depo testosterone 1ml 200mg.Tapped out the air and left it leaning against a basket with the needle cover not clicked on but on the needle for protection.My wife performs this injection for last 15 years going left or right every other injection.She wiped the pre injection spot with alcohol swab.Picked up the syringe and the needle blew off of the syringe emptying the entire contents in under a second, just by touching the sides of the syringe.There is no bio hazard because the syringe was never used it just exploded!".

Manufacturer Narrative

H6: investigation summary: it was reported the needle blew off of the syringe.As sample was not returned, a thorough sample investigation could not be completed.Since no samples displaying the reported condition were received, a potential root cause could not be defined.A device history record review was completed for provided material number 305270, lot 0329605.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 0329605 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

Event Description

It was reported that the needle of the bd integra¿ syringe with detachable needle "blew off" the syringe right before the injection, spilling out depo testosterone.The following information was provided by the initial reporter: "i set up an injection that is inter muscular injection , that i have been doing once a week for 15 years.I loaded the bd integra syringe with depo testosterone 1ml 200mg.Tapped out the air and left it leaning against a basket with the needle cover not clicked on but on the needle for protection.My wife performs this injection for last 15 years going left or right every other injection.She wiped the pre injection spot with alcohol swab.Picked up the syringe and the needle blew off of the syringe emptying the entire contents in under a second, just by touching the sides of the syringe.There is no bio hazard because the syringe was never used it just exploded!".

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16005241
• MDR Text Key: 308537831
• Report Number: 1213809-2022-01272
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: 0329605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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