MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD NEEDLE ECLIPSE 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305829
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 25x5/8 needle was clogged / blocked.The following information was provided by the initial reporter: customer response on feb 03, 2025 follow-up 2 for (b)(4).My provider has encountered in the past couple weeks (prior to (b)(6) 2025) the bd eclipse needle 305829 unusable, due to being "plugged" cannot push medication.It does not happen with every needle.We pulled the needles and set aside at this time.I checked the website and did not see a recall.Have there been any additional reports? two occurrences at the location, but the provider noted occurrences at other locations.I do not have the information regarding lot# etc.
Event or Problem Description
Samples received.
Additional Manufacturer Narrative
Investigation summary: this complaint was opened due to multiple events being reported.The samples received from customer were investigated under pr (b)(4).The investigation summary is as follows: "69 unused samples were received and tested by our quality team.The needles were all tested by drawing air and injecting it then drawing water and injecting to determine if a clog could be found.There were no issues or abnormalities found with any of the unused sets.The manufacturer was contacted for further investigation.From manufacturer: there were notifications identified during the dhr review that may have contributed to the needle being blocked.It was identified that a notification was written for incomplete hubs and a blocked through hole at the molding manufacturing site.All inspections completed at final manufacturer were complete.Due to these quality notifications the complaint can be verified without affected device being tested and the root cause is due to manufacturer quality error.The manufacturing issue has since been resolved.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• 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: 21438622
• Report Number: 1920898-2025-00005
• Device Sequence Number: 20004426
• Product Code: FMI
• UDI-Device Identifier: 00382903058297
• UDI-Public: (01)00382903058297
• 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): 05/01/2025

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: 305829
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown