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

Model Number 305270

Device Problem Leak/Splash (1354)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported while using bd integra¿ 3 ml retracting safety syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported the defective syringe, bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).Patient came into receive second dose of shingrix vaccine.Upon administration the vaccine expelled out where the needle attaches to the barrel of the syringe.The syringe was a bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).Type of event: malfunction.

Manufacturer Narrative

E.4.: the initial reporter also notified the fda on (b)(6)2023.Medwatch report # mw5118426.H.3.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.

Event Description

It was reported while using bd integra¿ 3 ml retracting safety syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported the defective syringe, bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).Patient came into receive second dose of shingrix vaccine.Upon administration the vaccine expelled out where the needle attaches to thebarrel of the syringe.The syringe was a bd integra syringe 3ml 25g x 1 (0.5mm x 25mm).Type of event: malfunction.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17339313
• MDR Text Key: 319761773
• Report Number: 1213809-2023-00740
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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: 0027028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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