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

Catalog Number	305766
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that the package is easy to puncture, and a few have been punctured easily.Package lacks an inner coating ex, plastic to prevent an easy puncture before the product is used.Complaint via email.Details of product complaint: 1.Product code ¿ bd305766 2.Meditech number ¿ 142334 ¿ this is a stocked item for xxx 3.Lot number - 5239830 4.Product description - needle hypodermic 18g 1.5inch hinged - bd eclipse safety 5.Date of incident ¿ (b)(6) 2026 6.Product complaint - the package is easy to puncture, and a few have been punctured easily.The package lacks an inner coating ( ex , plastic) to prevent an easy puncture before the product is used.7.Supplier ¿ xxxx 8.Infection control issue ¿ yes as the package is no longer sterile and has an increased risk of infection 9.Package sample is available for return.
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 photo and 8 samples submitted for evaluation.The reported issues of package damaged/ defective were confirmed upon inspection of the samples.Analysis of the samples showed the top web was torn on all 8 blister packages.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 primary packaging process was reviewed.The root cause is the blister packaging being crushed during packaging.This occurred when the height of the stacked blister packages exceeded the designated clearance, leading to contact with the cylinder.Action had been taken to install a height check sensor to stop the line when improper stacking is detected.The affected lot was manufactured prior to the implementation of this corrective measure.

• 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: 24790431
• Report Number: 2243072-2026-00258
• Device Sequence Number: 13193567
• Product Code: FMI
• UDI-Device Identifier: 00382903057665
• UDI-Public: (01)00382903057665(11)250827(17)300731(10)5239830
• 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,Followup
• Report Date (Section B): 05/13/2026

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: 305766
• Device Lot Number: 5239830
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown