MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 305838 batch#: 2355492.It was reported that the bd needle eclipse 25x1-1/2 rb needle was clogged/blocked.The following information was provided by the initial reporter.Verbatim: event date: 8-7-2024 event location: xxxx event description: ¿while pa was completing a joint injection on a patient, the needle wouldn't allow the medicine to inject.She changed out needles to another new one and it did the same thing again.Needle 25 g x 1 1/2" bd eclipse needle lot 2355492 exp 12/31/2027¿ harm to team member or patient? no injury to my knowledge.Product name: itm-1150133 - needle safety 25g x 1.5 product ref: 305838 lot number: 2355492 bd customer account number: (b)(6).Actual product involved is not yet available for return.
Additional Manufacturer Narrative
Investigation summary: 5 unused needles were received and tested by our quality team.The samples were tested by aspirating plunger while attached to syringe and injecting with both air and water.The needles presented no issues and the complaint of clogged needles could not be verified.The root cause cannot be determined without more information like the used needles.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): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• 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: 20060865
• Report Number: 1920898-2024-00137
• Device Sequence Number: 20912309
• Product Code: FMI
• UDI-Device Identifier: 00382903058389
• UDI-Public: (01)00382903058389
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 305838
• Device Lot Number: 2355492
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 08/25/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown