MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE; ANTI-STICK SYRINGE

Model Number 305270

Device Problems Complete Blockage (1094); Leak/Splash (1354)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported while using bd integra¿ 3 ml retracting safety syringe there was a crack and leakage occurred.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: when injecting the vaccine, the contents of the syringe came out of the luer lock area and ran down the patient's arm.This happened twice.Also had found syringes with cracks in the area of the luer lock.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.

Event Description

It was reported while using bd integra¿ 3 ml retracting safety syringe there was a crack and leakage occurred.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: when injecting the vaccine, the contents of the syringe came out of the luer lock area and ran down the patient's arm.This happened twice.Also had found syringes with cracks in the area of the luer lock.

• Brand Name: BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE
• Type of Device: ANTI-STICK 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 ; 8448235433
• MDR Report Key: 16475808
• MDR Text Key: 310632498
• Report Number: 1213809-2023-00140
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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: Other
• Device Model Number: 305270
• Device Catalogue Number: 305270
• Device Lot Number: 9294200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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