MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ECLIPSETM NEEDLE 23G X 1"TW

Catalog Number	305826
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipsetm needle 23g x 1"tw safety mechanism failed.The following information was provided by the initial reporter: "when attempting to engage safety lock on a 23 g needle, the needle and cap disconnected from syringe and safety did not engage.No one was injured.".
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Updated codes.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD ECLIPSETM NEEDLE 23G X 1"TW
• Common Device Name: 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: 19377321
• Report Number: 1920898-2024-00121
• Device Sequence Number: 7538234
• Product Code: FMI
• UDI-Device Identifier: 00382903058266
• UDI-Public: (01)00382903058266
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: Health Professional
• Device Catalogue Number: 305826
• Device Lot Number: 3046198
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown