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

Catalog Number	305829
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.4.Other lot number includes unknown and other expiration date includes unknown.H.4.Other lot number device manufacture date is unknown.
Event or Problem Description
Materials #: 305829, batch #: unknown, 3330684 and 2271572.It was reported that the bd eclipsetm needle 25g x 5/8"tw safety shield broke off (eclipse).The following information was provided by the initial reporter: "eclipse needles safety activation is breaking." verbatim: rcc received a complaint via phone.Pir attached.Product complaint: mds.Contact: manger dept: ambulatory.Contact: director of ambulatory quality managment.Issue: eclipse needles safety activation is breaking.Ref: (b)(4).Lot: unknown, 3330684 and 2271572 doe: multiple doe will send them when the acknowledgement is sent out.Pt harm: no.Additional information provided: dates of occurrences: (b)(6) 2024 (four different users reporting this issue).I do not have notes of what lot numbers impacted which dates.If we have additional occurrences, i will make sure to have the staff notate this.We had several occurrences before this was noted to be a significant risk event.
Event or Problem Description
Samples received.
Additional Manufacturer Narrative
Investigation summary: three photos were received and investigated by our quality team.The photos presented a detached safety shield like customer complained- which verified the issue.The root cause of this failure is not known due to the device history record review having no quality issues and the physical sample not being received for further investigation.There are also no errors detected in photos with exception of safety shield being off.

• Brand Name: BD ECLIPSETM NEEDLE 25G X 5/8"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: 19463193
• Report Number: 1920898-2024-00126
• Device Sequence Number: 12425267
• Product Code: FMI
• UDI-Device Identifier: 00382903058297
• UDI-Public: (01)00382903058297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/14/2024

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: 305829
• Device Lot Number: 2271572
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/04/2024
• 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
• Patient Sex: Unknown