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

Catalog Number	305765
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 21x1-1/2 rb tw package damaged / defective it was reported by the customer that a tear in the paper tyvek backing of a needle pouch was detected during packaging operations.Verbatim: rcc received a complaint via email.Email(s) attached.During packaging operations, one needle pouch was detected with a tear in the paper tyvek backing.The tear was miniscule and observed by the aql inspector.
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 5 samples submitted for evaluation.The reported issue of packaging defective/ damaged was confirmed upon inspection of the samples.Analysis of the samples showed the top web torn on two of the five blisters.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 probable cause of the package damage is shrinkage of the bottom web material at the sealing station.This shrinkage caused the forming to become skewed and resulted in a "blister up" effect, which led to the part being positioned outside its designated pocket during the sealing process.As a result, the part rubbed against the top web, causing puncture marks on the blister's top web.Action has been taken to ensure the part remains correctly seated in its designated pocket by adding a pocket presser to the packaging process in september 2024.However, the affected lot was manufactured in april 2024, prior to the implementation of this corrective action.Current control is a visual inspection for damaged packages at the quality assurance outgoing and in-process inspections.

• 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: 22509255
• Report Number: 2243072-2025-00870
• Device Sequence Number: 18327088
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: (01)00382903057658(11)240403(17)290331(10)4084131
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 305765
• Device Lot Number: 4084131
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown