MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305838
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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
Material #:305215.Batch#:2355495.It was reported that the bd needle eclipse 25x1-1/2 rb needle was clogged / blocked.The following information was provided by the initial reporter: it was reported by customer that they had an issue with some 25g needles.On 3 separate occasions the needles have clogged, and the injection was not able to be completed.The patient unfortunately had to be stuck a second time.The needles are al the same lot number, so we pulled them from the shelf until we had a plan of action.Additional information provided: i noticed the email states that we are at (b)(6).The incident occurred one time on (b)(6) 2024 and then occurred twice on (b)(6) 2024.The lot number is 2355495, no other lots are affected.Please see the pictures below.A shipping label can be sent to: (b)(6).
Event or Problem Description
Samples received.
Additional Manufacturer Narrative
Investigation summary: 3 samples were received and tested by our quality team.The sets were visually inspected and there seemed to be a white chalky substance inside of needle.The sets were then functionally tested and one needle had an initial clog when attempting to inject and aspirate with water.The complaint was verified once a clog was realized.The clog was not experienced for the other 2 syringes and the syringe with clog was cleared of issue after a small application of pressure to plunger.The root cause of this issue is unknown but possible due to the viscosity of the medicine being administered.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 20248315
• Report Number: 1920898-2024-00143
• Device Sequence Number: 7365989
• Product Code: FMI
• UDI-Device Identifier: 00382903058389
• UDI-Public: (01)00382903058389
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/15/2025

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: Health Professional
• Device Catalogue Number: 305838
• Device Lot Number: 2355495
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown