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

Catalog Number	305270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 25x1 rb needle was broken, the following information was provided by the initial reporter: material#: 305270 batch#: 2244656.Rcc received a complaint via phone.Pir attached.Customer states that he is using the integra syringe and 3 needles broke off and are in his leg.Customer said that his doctor said he would have to have surgery to remove them.Customer has product to return if needed for investigation.Ref#: 305270 lot#: 2244656 additional info received: it was 3 separate instances over the last month.The last one was on (b)(6).I have been giving myself shots since 2017-2018 without a problem.I got these syringes and the problems began.I now have 3 needles stuck in my muscle.Can you confirm if an x ray was done to check for a needle in the leg? has there been any medical intervention so far? any pain medications? any swelling at injection site or current signs of infection? any surgery date scheduled? none.I found out 2 days ago the syringe retracts the needle, so i do not believe there are needles in my leg.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle broken.One sample of the 3 ml integra syringe with a 25 x 1" needle attached (part number 305270, lot 2244656) was received in an unsealed package containing all required product information.The syringe was evaluated and found to have no defects, and the needle cannula was confirmed to be positioned inside the inner plunger rod as designed.The observed condition meets product specifications, and it is important to note that this model includes a retractable needle feature in which the metal cannula retracts into the inner plunger rod for safety.A device history record review for this lot showed that all in process and final inspections were completed as required, with no quality notifications related to the reported condition.The lot met all acceptance criteria, was approved for shipment, and complies with applicable product specifications.Complaints for this device and condition will continue to be tracked, trended, and reviewed regularly by the business team to monitor for any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: INTEGRA PRECISIONGLIDE
• 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: 24153921
• Report Number: 1213809-2026-00025
• Device Sequence Number: 10669908
• Product Code: MEG
• UDI-Device Identifier: 00382903052707
• UDI-Public: (01)00382903052707(17)270831(10)2244656
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/03/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 305270
• Device Lot Number: 2244656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown