MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.; ANTISTICK SYRINGE

Model Number	305271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with bd integra¿ 3 ml retracting safety syringe with 23 g x 1 in.The needle broke off and remained in patient.Patient went to er to have it removed.The following information was provided by the initial reporter: pharmacist called in as customer was using integra syringe for testosterone during injection in gluteal the needle broke off and remained in patient.Patient is on their way to er to have it removed.Lot# 0325703.
Additional Manufacturer Narrative
Investigation summary: no samples or photos received by our quality team for evaluation.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety when adequate pressure is applied to the inner plunger rod.Since the condition is related to customer awareness a potential root cause could not be established and corrective actions are not necessary.The reported condition is related to a customer awareness issue, therefore a device history review is not required.
Event or Problem Description
It was reported that during use with bd integra¿ 3 ml retracting safety syringe with 23 g x 1 in.The needle broke off and remained in patient.Patient went to er to have it removed.The following information was provided by the initial reporter: pharmacist called in as customer was using integra syringe for testosterone during injection in gluteal the needle broke off and remained in patient.Patient is on their way to er to have it removed.Lot# 0325703.

• Brand Name: BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.
• Common Device Name: ANTISTICK 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: 16492963
• Report Number: 1213809-2023-00154
• Device Sequence Number: 6536745
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2025
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 0325703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown