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

Catalog Number	305269
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 ll w/ndl 25x5/8 rb had leakage.The following information was provided by the initial reporter: the syringe/needle combination leaked.Discovered by: site nurse.Date of discovery: (b)(6) 2025.Date of occurrence: (b)(6) 2025.Item number: 305269.Lot number: 0259746.When the study drug was being administered, the nurse noticed some drops of the study drug had leaked out.Administration was stopped and the needle/syringe was assessed.The needle of the syringe was replaced and the remainder of the study drug (0.7 ml) was administered without issue.The total volume of study drug at the beginning was 1.6ml but it is unclear how much had leaked; therefore, it is unknown how much of the study drug was administered.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage an investigation was conducted on two samples of the 3ml integra syringe with a 25x5/8¿ needle (part number 305269) from batch 0259746.The samples were received in sealed packaging and underwent visual inspection and functional testing.No defects or leakage were observed, and the reported issue could not be replicated.The condition of the samples was found to be within product specifications.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 0259746.All visual inspections were performed as per requirement with one quality notifications related to the complaint defect.Batch 0259746 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.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: 22057107
• Report Number: 1213809-2025-00341
• Device Sequence Number: 15552102
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)200915(17)250831(10)0259746
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 305269
• Device Lot Number: 0259746
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown