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

Catalog Number	305761
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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 25x1 rb safety mechanism failed it was reported by the customer that they have encountered issues where the needles either broke when being removed from the packaging, split at the end where they connect to the vaccine syringe, or led to a safety incident in which a staff member was poked by the needle due to a malfunction.Rcc received a complaint via email.We have received a quality complaint on product sold to our customer.Injuries or adverse event: no item: 305761 quantities affected:2ea serial/lot number: (b)(6), po : (b)(4) are any samples available for return? yes, reported issue: per customer xxx: over the past two months, we have experienced two incidents involving patients and employees related to the bd eclipse needles, 25g x 1.We have encountered issues where the needles either broke when being removed from the packaging, split at the end where they connect to the vaccine syringe, or led to a safety incident in which a staff member was poked by the needle due to a malfunction.To ensure safety, i have removed these needles from our inventory and replaced them with the magellan safety needle, 25 g x 1".Customer disposition request: customer contact information: xxx additional information received on 30dec2025.The exact dates of the incidents - (b)(6) 2025.
Additional Manufacturer Narrative
Our quality engineer inspected the photo and 600 representative samples submitted for evaluation.The reported issue of needle hub hole/ cracked/ damaged was not confirmed upon inspection of the sample.Analysis of the sample showed no damage or defects.The samples were subjected to a safety shield inspection to check for hub hook breakage or for safety shield fall off and the samples passed.An activation/ locking for test was also performed and no abnormalities were observed.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 defect was not replicated.

• Brand Name: ECLIPSE
• 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: 24059210
• Report Number: 2243072-2026-00012
• Device Sequence Number: 9875233
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(10)5025051
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 305761
• Device Lot Number: 5025051
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown