MAUDE Adverse Event Report: BECTON DICKINSON ECLIPSE LUER-LOK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 25x1 rb leaked it was reported by customer that they noted leakage from hub of needle.Verbatim: rcc received a complaint via email.Email(s) attached.(b)(6) mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2025 site name/location: level of harm: (b)(6) optional report to (b)(4): incident details: client came to clinic for influenza vaccine.During immunization to patient's left arm at 17:25hrs writer noted leakage from hub of needle.Writer informed (b)(6), writer advised to readminister vaccine as patient did not receive a full dose.Writer explained this to the patient, patient agreeable to have the flu vaccine re administered.Writer readministered a second influenza vaccine to right arm and immunization was effective.Client understanding of situation.Impact of incident: who was affected? patient frequency of problem: other device/incident factors: invasive procedure? procedure: resulted in a double poke for a patient physician: device information device name/description: syringe 3ml with needle safety 25ga x 1 in manufacturer: becton dickinson canada inc manufacturer code/model: 305787 serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): 2026-11-30.Supplier: (b)(4).Supplier catalogue number: 308-305787 was the device retained? no.
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
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: ECLIPSE LUER-LOK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23842690
• Report Number: 2243072-2025-01512
• Device Sequence Number: 18600840
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: (01)00382903057870(11)211126(17)261130(10)1330250
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: Health Professional
• Device Catalogue Number: 305787
• Device Lot Number: 1330250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown