MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305829
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 305829.Lot: 2271567.It was reported that the bd needle eclipse 25x5/8 needle hub had a hole / was cracked / damaged.The following information was provided by the initial reporter: it was reported by customer that luer lock at base of needle attaches to syringe tip was deformed.Verbatim: rcc received a complaint via email.Patient received injection in main atc and needle used for injection noted to be defective.On further inspection, needle hub (where luer lock at base of needle attaches to syringe tip) was deformed.This was noted with bd eclipse 25g x 5/8" (0.5mm x 16mm) sterile needle.Lot number 2271567.Reference number (b)(4).Manufactured 10/1/22 and expires 9/30/27.Patient unharmed and device replaced with new needle.Patient received medication and patient's md emailed for further follow up if necessary.
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
Codes updated.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• 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: 20343209
• Report Number: 1920898-2024-00146
• Device Sequence Number: 7895581
• Product Code: FMI
• UDI-Device Identifier: 00382903058297
• UDI-Public: (01)00382903058297(11)220928(17)270930(10)2271567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/14/2025

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: Health Professional
• Device Catalogue Number: 305829
• Device Lot Number: 2271567
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown