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

Catalog Number	305837
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
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 needle was broken.The following information was provided by the initial reporter: "the tip of the needle broke." injuries or adverse event: no.Medline reference #: (b)(4).Item: 305837.Quantity affected: 2 bx.Serial/lot number: (b)(6).Po #: (b)(4).Are any samples available for return? yes reported issue per customer: customer michaela emailed to report the tip of the needle broke.Pictures attached.Replacement requested.Lot 2305839.Customer disposition request: replacement.
Additional Manufacturer Narrative
Investigation summary: two photos were received and analyzed by our quality team with the customer's complaint of broken needles.The photos clearly show the broken needles and the complaint has been verified but the root cause of failure cannot be determined without the physical sample for investigation.There were no notifications identified during the dhr review that may have contributed to the tip of the needle breaking off.All inspections were complete and acceptable (batch#: 2305839).Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
Event or Problem Description
Photos 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: 18700419
• Report Number: 1920898-2024-00059
• Device Sequence Number: 6194661
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/04/2024

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: 305837
• Device Lot Number: 2305839
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown