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

Catalog Number	305270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
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 had leakage at the luer connection.The following information was provided by the initial reporter: material # 305270 lot # 1315713.It was reported by customer that the medication leaked out of the syringe at the tru-lok connection with the needle and onto the skin.Verbatim: rcc received a complaint via email.Patient self-administers cyanocobalamin (b-12) using the bd integra syringe with pre-attached bd precision glide needle.During administration, the medication leaked out of the syringe at the tru-lok connection with the needle and onto the skin.Administration was stopped, but patient is uncertain how much of the dose was actually injected.Package, syringe, and needle are all available upon request.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - leakage at luer connection.One sample of a 3ml integra syringe with a 25x1¿ needle (part number 305270, batch 1315713) was received and evaluated.The syringe and needle were received in an unsealed package and inspected with no defects observed.The needle cannula remained securely attached to the hub, and leak testing confirmed that neither the needle nor the syringe leaked.The plunger rod was fully depressed, and the needle retracted as designed.The accompanying photo showed one loose syringe next to the packaging, with the syringe empty and the shield partially filled with an unknown red fluid.The reported defect could not be confirmed based on the photo provided.It is recommended to hand-tighten the needle onto the syringe prior to use to ensure secure attachment.Furthermore, a device history record review was completed for provided lot number 1315713.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.
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: 22007046
• Report Number: 1213809-2025-00336
• Device Sequence Number: 20172208
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708(10)1315713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/10/2025

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: 1315713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown