MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305759
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.As neither a lot number nor a sample was available for this incident, a complete investigation could not be confirmed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd needle eclipse 25x5/8 had leakage.The following information was provided by the initial reporter: material: 305759 batch#: unknown (provided lot#2006005) verbatim: rcc received a complaint via email.Email(s) attached.Reference number (id): (b)(4) date of incident: (b)(6) 2025 level of harm: no apparent harm - reached the patient/person -- inconvenient incident details: writer was administering prn dilaudid 6mg (0.6ml), when plunger was pushed, the entirety of the medication spilled out the side of the syringe at the leur-lock site despite no cross threading of the needle to the 1cc syringe.Writer informed charge nurse of this and showed the medication present on the patient's sweatpants to aid as evidence that no amount of the medication was administered.Writer pulled another vial and administered the medication with a different syringe (tuberculin syringe with needle already attached).Other coworkers have noticed issues with this same product, it is soley manufacturer error as writer ensured no cross threading.Product does not fit on 1cc syringe.Product: bd eclipse needle 25g x5/8 (0.5mm x16 mm) injection needle lot #: 20066005 device name/description: needle hypodermic safety 25ga x 5/8 in eclipse manufacturer code/model: 305759 serial or lot number: (b)(6) device expiry date: 2025-05-28 supplier catalogue number: 308-305759 was the device retained? no.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 22047775
• Report Number: 2243072-2025-00660
• Device Sequence Number: 8908734
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Catalogue Number: 305759
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown