MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 30X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305757
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 30x1/2 needle clogged/blocked.It was reported by customer that the injection needle was clogged so i had to use a different one.Rcc received a complaint via email.Patient states ¿one time 1 of the syringes in the kit didn¿t have a plunger in it so i just used the same syringe to withdraw the sterile water and the egrifta.Another time, the injection needle was clogged so i had to use a different one.¿ patient no longer has either product on hand still.The report mentions that one of the bd 1ml syringes in the kit didn¿t have a plunger in it.Unfortunately, the lot number of the injection kit or syringe is not available.
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 NEEDLE ECLIPSE 30X1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21287247
• Report Number: 2243072-2025-00037
• Device Sequence Number: 21162234
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• 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): 01/17/2025

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: 305757
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown