MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305109
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 27x1/2 rb had leakage at the luer connection.The following information was provided by the initial reporter: material#: 305109.Batch#: 4212451.Verbatim: (b)(4) report.Incident or problem information: (b)(4) reference number (id): (b)(4).Date of incident: (b)(6) 2025.Site name/location: (b)(4).Level of harm: no apparent harm - reached the patient/person -- inconvenient (b)(4) optional report to (b)(4) (health canada): incident details: client used 3 ml bd luer-lok syringe and bd precision glide needle tip to self-inject medication.While self-injecting, client noted that medication was leaking into luer lok hub.Writer noted that needle tip was correctly attached and secure.Assisted client in changing needle tip.Unknown small amount of medication wasted in luer-lok.Device information: device name/description: syringe luer lock tip 3ml.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 309657.Serial or lot number: (b)(6).Device expiry date: 2025-10-31.Supplier: (b)(4).Supplier catalogue number: (b)(4).Was the device retained? no.Investigation request: expected type of investigation: lot review.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up.A device history record review was completed by our quality engineer team for provided material number 305109 and lot number 4212451.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect similar issues during the production process.Further action has not been determined necessary at this time.

• Brand Name: BD PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22680841
• Report Number: 1911916-2025-00548
• Device Sequence Number: 12996126
• Product Code: FMI
• UDI-Device Identifier: 00382903051090
• UDI-Public: (01)00382903051090(17)290930(10)4212451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 305109
• Device Lot Number: 4212451
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown