MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ECLIPSETM NEEDLE 25G X 5/8"TW; ECLIPSE NEEDLE

Catalog Number	305829
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.4.The initial reporter also notified the fda, march 2024.Medwatch report is (b)(4).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd eclipsetm needle 25g x 5/8"tw safety shield broke off.The following information was provided by the initial reporter: "rn was administering sub q heparin to patient.After administering, she pushed safety device to cover needle, but the device broke off at the hinge and the rn was stuck with the dirty needle.Needlestick - blood/bodily fluid exposure." rn seen by the employee health department.
Additional Manufacturer Narrative
Updated codes.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD ECLIPSETM NEEDLE 25G X 5/8"TW
• 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: 19034943
• Report Number: 1920898-2024-00107
• Device Sequence Number: 7042162
• Product Code: FMI
• UDI-Device Identifier: 00382903058297
• UDI-Public: (01)00382903058297
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305829
• Device Lot Number: 2207202
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown