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 Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material#: 305829.Batch number#: 2271567.It was reported that the bd eclipse needle 25g x 5/8"tw had a safety mechanism failure.The following information was provided by the initial reporter: "we have had two needle sticks related to this needle and the safety mechanism breaking ad not latching." additional information provided: 1.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.There was no patient harm related to the events.With the first needlestick the patient was affected because they had to have labs drawn for screening because they had already been given their vaccines when staff was stuck with the needle.2.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes ,we have pulled the affected lot number off of our shelves and replaced with back stock.We are able to ship all affected items back for inspection.3.Please confirm whether it is a contaminated/uncontaminated needle stick injury.This will be a contaminated needle, from the description above the needle was used to administer the vaccines needed ate the time of visit.
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
Samples received.
Additional Manufacturer Narrative
Investigation summary: 95 unused samples were received and tested by our quality team.The safety shield issue was verified with the photos provided by customer.After functional tests with all 95 of the shields there were no issues.The device history record review did expose possible root causes even though the issues were resolved.The root cause remains unknown and the manufacturer has been notified.

• 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: 19533221
• Report Number: 1920898-2024-00129
• Device Sequence Number: 18068581
• Product Code: FMI
• UDI-Device Identifier: 00382903058297
• UDI-Public: (01)00382903058297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/14/2024

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: 2271567
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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