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

Catalog Number	305759
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 25x5/8 - safety mechanism failure.Material#: 305759.Batch#: 4250308.It was reported by customer that safety lock on needle did not secure leaving sharp exposed and when disposing needle in sharps container poked employee through gloves into thumb producing blood.
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
Our quality engineer inspected the photos submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the photos.From the returned photo, the safety shield was observed to be engaged and securely locked into the hub, indicating that the safety mechanism was properly activated.Hence, the cannula was found to be slightly bent, which resulted in partial exposure.Current control is an in-process visual inspection for broken cannula catch/cannula lock pin in the eclipse safety shield molding process.There is also a dimensional measurement for hub hook inner diameter during the eclipse hub molding process.There is and in-process visual inspection for damaged pivot pins at the assembly and packaging process.There is also a daily functional test in place to check for activation/locking force.Per the instructions for use (ifu), it is recommended that for safety activation: 1.Center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it lock.Visually confirm that the needle is covered.2.Only use the wide textured finger pad area to activate the safety cover.The physical sample was not returned so the root cause could not be determined.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: NEEDLE ECLIPSE 25X5/8
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22794330
• Report Number: 2243072-2025-00993
• Device Sequence Number: 20899152
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)240909(17)290831(10)4250308
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 4250308
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown