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	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Materials #: 305837, batch #: 2125855.It was reported that the bd needle eclipse 25x1 rb was clogged/blocked.The following information was provided by the initial reporter: the 1st needle was discovered on 5/16/24 and the safety zone portal incident (b)(4) was created: details: ¿patient was scheduled for hepatitis a vaccination.Writer attempted to administer hepatitis a vaccine in left deltoid but plunger would not depress.Writer removed needle from patient's deltoid and activated safety feature.Writer apologized to patient and asked if patient still wanted to receive hepatitis a vaccination, patient was agreeable.New vaccine hepatitis a vaccination administered in left deltoid with success.After patient left writer further examined vaccine and needle, the 25 gauge 1 inch needle did not have a hole in it.Writer notified clinic coordinater (b)(6).¿ we didn¿t file a complaint with bd because we didn¿t have the specific needle packaging with lot number.We suspected it was from bd eclipse lot 2125855.Additional information provided: 1.How was the patient outcome? are there any clinical signs, health consequences or impact? pt had to be poked twice.2.Any adverse event or serious injury reported to patient or health care professional? second poke for patient and visit took longer.3.Any physical sample or photo available for investigation of affected product? if yes, are you able to provide the address of the facility for us to ship the return label? no ¿ needle was not saved in either accounts nor was a photo taken.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Codes updated.
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: 19534312
• Report Number: 1920898-2024-00130
• Device Sequence Number: 20967669
• Product Code: FMI
• UDI-Device Identifier: 00382903058372
• UDI-Public: (01)00382903058372
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/19/2024

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 Catalogue Number: 305837
• Device Lot Number: 2125855
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown