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

Catalog Number	305837
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material: 305837 lot:2111820 it was reported that the bd needle eclipse 25x1 rb safety mechanism failed.The following information was provided by the initial reporter: verbatim: rcc received a complaint via phone.Pir attached.Product complaint - customer called to report that while she was vaccinating a pt.The needle broke away from the syringe and got stuck in a patient, she experienced a needle stick injury ref: 305837 lot 2111820, doe 05/02/2024 , the medication spilled every where and unsure if the pt received full dosage of the vaccination.She collected blood sample from the patient to test for any communicable disease.She also advised that another nurse has experienced such incident where the needle detached from the syringe causing a needle stick injury as well and she thinks it is from the same lot number.She further narrated how this has happened in the past, last year and same incident especially with this very type of needle but it was not reported to bd, only to their safety department.Additional information provided on 5/8/2024: 1.I do not have any photos to provide as i disposed of the needle in the sharp's container.2.The needle was contaminated with client's blood before i stuck myself.3.Patient was not impacted.4.This is the third time in the last couple of months that we are experiencing the same issue when we use this needle.The plastic appears to be weak and breaks off when the medicine is injected.Another issue is that the safety glide falls off easily on these needles (this happens often).Multiple employees experiencing the same issue and another employee experienced a needle stick injury after using this brand needle.Additional information provided on 5/30/2024| 1) was the additional needle stick the result of the safety mechanism detaching? 2) was the additional needle stick clean or contaminated? 1.Yes 2.Needle stick was contaminated with patient's blood.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Codes update.
Event or Problem Description
Imdrf codes must be updated.

• 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: 19443293
• Report Number: 1920898-2024-00124
• Device Sequence Number: 20624299
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305837
• Device Lot Number: 2111820
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown