MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305712
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd eclipse¿ needles there was coring.The following was recieved by the initial reporter: multiple coring issues using bd blunt fill and eclipse needles while drawing up medications.They have samples of each: 305211 and 305712 to be investigated by bd.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: one sample was received and tested by our quality team.The customer complained of coring needle with difficulty drawing medication.The needle tip was analyzed under a high power digital microscope and there was a slight noticeable edge to needle tip.The complaint has been verified with this finding.The root cause of this failure is unknown but possibly due to improper needle point formation.Cannula condition is inspected each hour during production, looking specifically for hooked/damaged point, double, inverted, and bent/blunt cannula (which may contribute to the experienced coring).Inspection records did not indicate any nonconformances.All assembled needles also pass under the point inspect machine.All parts are considered "bad" until they meet certain requirements to pass as "good".The point/grind is how the inspection camera looks at the bevel and if the point was damaged it would call the part bad and would reject it.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Samples received.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17830835
• Report Number: 1920898-2023-00659
• Device Sequence Number: 17575275
• Product Code: FMI
• UDI-Device Identifier: 00382903057122
• UDI-Public: (01)00382903057122
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/30/2024

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: 305712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown