MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305782
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/ndl eclipse 23x1 rb had leakage at the luer connection.The following information was provided by the initial reporter: material # 305782 , batch # 4187641.Verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer, and include complaint# (b)(4) on any future communications.Injuries or adverse event: no.Item: 305782.Quantity affected:1cs.Serial/lot number: (b)(6).Po : (b)(6).Are any samples available for return? yes.Reported issue: the item is leaking when attached to an extension set; leaking where luer connector meets the set.This is happening on only this syringe and issue does not occur when using a different product from bd.Customer disposition request: replacement.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.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 3 samples submitted for evaluation.The reported issue of leakage at luer connection was not confirmed upon inspection of the samples.Analysis of the samples showed no damage or defects.The samples were subjected to a leak 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 were reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 22075200
• Report Number: 2243072-2025-00675
• Device Sequence Number: 20932122
• Product Code: FMI
• UDI-Device Identifier: 00382903057825
• UDI-Public: (01)00382903057825(11)240709(17)290630(10)4187641
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/09/2025

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: 305782
• Device Lot Number: 4187641
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown