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

Catalog Number	305837
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4.The initial reporter also notified the fda on 15-jan-2024.Medwatch report is mw5150471.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 was clogged blocked.The following information was provided by the initial reporter: "when giving covid booster pharmacist went to depress the plunger to administer the vaccine and the plunger would not move.Pharmacist did note some resistance to expelling the air prior to administration but not to the point she found it alarming.Pharmacist attempted to give the vaccine a second time only to find the same issue.After fiddling with the vaccine pharmacist ruled the vaccine to be compromised and patient elected to get the vaccine another day.After further scrutiny it looks like the failure was in the bd eclipse needle, as in comparison to another needle appeared to have a slight band near the end of the needle, possible indicating a manufacturing error or blockage.".
Additional Manufacturer Narrative
Investigation results: no photo or sample was received for the customer's complaint of needle clogged.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.There were no notifications identified during the dhr review that may have contributed to the clogged needle.All inspections were complete and acceptable (lot#: 1217268).
Event or Problem Description
No additional information.

• 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: 18672789
• Report Number: 1920898-2024-00044
• Device Sequence Number: 6194681
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• 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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 305837
• Device Lot Number: 1217268
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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