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

Catalog Number	305837
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
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
It was reported that the bd needle eclipse 25x1 rb safety shield broke off.The following information was provided by the initial reporter: "safety part came off" "two instances where the safety part came off and this last time employee was stuck because the safety guard came off." material #: 305837 batch#: 2046337, 2077251, 2091800.I have attached information on the product i received for this adverse event complaint.I would like to request a ra# and the return address, so i can return the product for evaluation and credit.For the freight charges, would you be able to email me a label or let us know your shipping account number? the address here is (b)(6).If you have any questions please let me know.(b)(6).Item#305837.Lot#2046337,2077251, 2091800.
Additional Manufacturer Narrative
Investigation summary: 300 unused samples were received with the customer's complaint of safety shields breaking off.Since the affected sample was not received, a random sampling of needles were selected and 50 needles were tested to see if the safety shield could be removed during normal use situations.No issues were found.The root cause of this issue cannot be determined and without the affected sample the complaint cannot be verified.There were no notifications identified during the dhr review that may have contributed to the safety shield breaking off.All inspections were complete and acceptable.
Event or Problem Description
Samples received.

• 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: 18937708
• Report Number: 1920898-2024-00093
• Device Sequence Number: 12484189
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/24/2024

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: 305837
• Device Lot Number: 2077251
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown