MAUDE Adverse Event Report: BECTON DICKINSON ECLIPSE; SYRINGE

Catalog Number	305758
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that discovered needle to be faulty, as medication had leaked onto patient from needle attachment.Xxxxx mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): (b)(6) 2026 site name/location: (b)(6) xxxx optional report to cmdsnet (health canada): incident details: patient requested prn hydromorphone sq, post administration it was discovered needle to be faulty, as medication had leaked onto patient from needle attachment.Writer unable to determine what entered patient versus what leaked out, nursing note made and care team made aware.Procedure: subcutaneous medication administration.Device information device name/description: needle eclipse safety 27 gauge x 0.5 inch use with luer lock tip syringe manufacturer: becton dickinson canada inc manufacturer code/model: 305758 serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): 2030-03-31 supplier: (b)(4).Supplier catalogue number: 308-305758 was the device retained? no investigation request expected type of investigation: lot review; report history/trend analysis; clinical contact information primary clinical contact (cc on final report): manager (cc on final report): xxxxxx.
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
Investigation results: based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is an inspection on hub leak test assembly at the qa functional inspection.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when actual sample is received.
Event or Problem Description
No additional information.

• Brand Name: ECLIPSE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24415120
• Report Number: 2243072-2026-00117
• Device Sequence Number: 6051977
• Product Code: FMI
• UDI-Device Identifier: 00382903057580
• UDI-Public: (01)00382903057580(11)250402(17)300331(10)5085174
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 305758
• Device Lot Number: 5085174
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown