MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; SYRINGE, ANTISTICK

Catalog Number	305270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd integra needle broke.The following information was provided by the initial reporter: it was reported by customer that needle broke off very painful bruising with a nodule rcc received a complaint via email.Has an emergency bill needle broke off very painful bruising with a nodule.Contact name, number and email: (b)(6).Item(s): syringe needle.Additional information provided: the date this happened was (b)(6) 2024 lot number is 2349876 for the bd integra syringe 3ml 25gx 1.There was bruising and tenderness that lasted 5 or 6 days.Hello i have attached a pic of the syringe that the emergency room districted looking to see if the needle was inside.I also have a picture of the package and the lot number.Also a pic of one of the needles completely in-tacked.
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Three photos were provided to our quality team for investigation.Two photos show an unsealed package with all applicable product information, and one of these photo shows loose syringe is next to the package, and the syringe is damaged with a cut by the bd logo, also showing the cutter through the stopper.The next photo shows one fully intact syringe.The condition observed is acceptable per product specification.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.The reported defect was not identified in photos received.Therefore, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 2112343.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTEGRA
• Common Device Name: SYRINGE, ANTISTICK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20996698
• Report Number: 1213809-2024-00978
• Device Sequence Number: 9879457
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(11)221215(17)271130(10)2349876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Catalogue Number: 305270
• Device Lot Number: 2112343
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/21/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown