MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ECLIPSE NEEDLE 18G X 1 1/2

Catalog Number	305712
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse needle 18g x 1 1/2 was discolored.The following information was provided by the initial reporter: "our cath lab found a couple of the 18g x 1.5¿ (305712) needles in their stock with a bent tip and discoloration, i have attached a picture.They were the same lot #, 3173764.Wasn¿t sure if this was maybe just a one-off or if it is something the bd is seeing.I have one in my office if you need to send it off or anything.Just let me know." customer response for follow-up: 1.Is there any physical sample available for needle bent issue? kindly share it for investigation.I have one of the needles and the packaging for the second.2.Is there any physical sample or sample photos, videos available for discoloration issue? kindly share it for investigation.Attached.3.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no patient impact, product was caught before use.4.Kindly share the exact address details to send a return shipping label: (b)(6).
Additional Manufacturer Narrative
H.3.If a device evaluation and or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: one photo was received of a very bent needle tip.The customer's complaint was immediately verified.The root cause of this issue is unknown without further information like a physical sample but there is a possible root cause due to operator error during manufacturing.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue (batch#: 3173764).
Event or Problem Description
Photos received.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document#: (b)(4) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: eclipse.Device failure: discoloration / variation in color / cloudy.

• Brand Name: BD ECLIPSE NEEDLE 18G X 1 1/2
• 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: 18842166
• Report Number: 1920898-2024-00083
• Device Sequence Number: 7486021
• Product Code: FMI
• UDI-Device Identifier: 00382903057122
• UDI-Public: (01)00382903057122
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/03/2025

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: 3173764
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 06/04/2024; Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/26/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown