MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X1 RB; ECLIPSE NEEDLE

Catalog Number	305837
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle eclipse 25x1 rb safety mechanism failed (eclipse).The following information was provided by the initial reporter: "two instances where the safety part came off and this last time employee was stuck because the safety guard came off.".
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
Imdrf codes must be updated.

• Brand Name: BD NEEDLE ECLIPSE 25X1 RB
• Common Device Name: ECLIPSE NEEDLE
• 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: 18850225
• Report Number: 1920898-2024-00085
• Device Sequence Number: 7457998
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• 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): 08/15/2024

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: 305837
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown