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

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	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse needle 18g x 1 1/2 was was coring.The following information was provided by the initial reporter: "we have been having issues with the bd#305712 needles.The pharmacy uses them to mix drugs and are telling us they dull so when they puncture the vial to draw the drug out its not puncturing clean, it¿s pushing particle¿s down into the vial.We¿ve had a couple different lot #¿s that they have had issues with (lot# 305712 + 3096634)." additional information provided on 02/28/24: 1.Please provide the date of events for mentioned lots.Lot #3096634 event date 10/27/2023.2.As you mentioned that you had a same issue with two different lots, can you provide another lot number (except lot# 3096634)? lot #305712 event date 12/19/2023 3.Is there any physical sample or sample photos/videos available? kindly share it for investigation.Yes.4.Did the event directly, or indirectly involve a patient or user? no.5.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 18889172
• Report Number: 1920898-2024-00089
• Device Sequence Number: 18030075
• Product Code: FMI
• UDI-Device Identifier: 00382903057122
• UDI-Public: (01)00382903057122
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 02/29/2024

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: 305712
• Device Lot Number: 3096634
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown