MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 25X5/8; INTRAVASCULAR CATHETER

Catalog Number	305759
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305759, lot #5149514.It was reported by customer that this item is a sub and having problems with it, the pink cover is sometimes falling off which is the semd cover, to activate the semd cover you have to get your fingers very close to the needle, the needle is short so difficult to avoid, and rn had a needlestick injury.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Our quality engineer inspected the 5 representative samples submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.Samples were subjected to an activation/ locking force test and all samples passed with no abnormalities 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: NEEDLE ECLIPSE 25X5/8
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 23694884
• Report Number: 2243072-2025-01433
• Device Sequence Number: 16017022
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)250606(17)300531(10)5149514
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 305759
• Device Lot Number: 5149514
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown