MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305838
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
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.D.4.Other lot numbers include 2355494, 2306052, and 2210218.Other expiration dates include 2027-12-31 and 2027-10-31.E.1.Address was not located and (b)(6) was used.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.H.4.Other lot number device manufacture dates are 2022-12-21, 2022-11-02 and 2022-07-29.
Event or Problem Description
Material#: 305838, batch#: 2355494, 2306052, 2210218, 2210220.It was reported that the bd needle eclipse 25x1-1/2 rb was clogged / blocked.The following information was provided by the initial reporter: rcc received a complaint via email.Item: 305838, lot: 2355494.Po: (b)(4).Issue: after drawing medicine can only push syringe halfway.
Additional Manufacturer Narrative
Investigation summary: 116 unused samples of mixed lots (batch # 2355494, 2306052, 2210218, 2210220) were received and analyzed by our quality team with the customer's complaint of needle occlusion/ needle blockage.All needles were tested by drawing and injecting air then water and no needles showed any issues.There were no clogs or blockages noticed.The complaint could not be verified due to the needles functioning as usual and the root cause remains unknown.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Samples received.

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21404810
• Report Number: 2243072-2025-00106
• Device Sequence Number: 9557921
• Product Code: FMI
• UDI-Device Identifier: 00382903058389
• UDI-Public: (01)00382903058389
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: Other
• Device Catalogue Number: 305838
• Device Lot Number: 2210220
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown