MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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 bd needle eclipse 23x1 rb needle broke it was reported by the customer that band aid it was still bleeding and noticed what looked like a silver piece, small part of needle was stuck in the pt arm.Verbatim: rcc received a complaint via phone.Pir attached.Bd ref 305762-eclipse needle lot 2313900 issue: pharm admin depo to pt put band aid over site, pt went home and took band aid it was still bleeding and noticed what looked like a silver piece, small part of needle was stuck in the pt arm.Customer said she removed it and the bleeding stopped.Clinician did not notice anything wierd after med.Was administered.Doe (b)(6) 2025 actual device not available but representative samples are.Canada complaint task our canada team for sample return kit.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and 5 representative samples submitted for evaluation.The reported issue of needle broken/ leakage was not confirmed upon inspection of the samples.Analysis of the samples showed epoxy adhesives bonded with the cannula to the hub and secured the joint area.No damage was observed on the hub luer surface.The samples were subjected to a hub leak test and no leak was observed at the hub assembly.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the leak could not be recreated.

• Brand Name: BD NEEDLE ECLIPSE 23X1 RB
• 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: 22666204
• Report Number: 2243072-2025-00937
• Device Sequence Number: 12622490
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: (01)00382903057627(11)221109(17)271031(10)2313900
• 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): 08/19/2025

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: 305762
• Device Lot Number: 2313900
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown