MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305767
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after use with bd eclipse¿ needle 25 g x 1 1/2 in.Single use sterile the safety mechanism detached and the hcp received a dirty needlestick injury.Hcp had bloodwork performed, patient will be getting bloodwork tested.The following information was provided by the initial reporter: it was reported by customer that while one of the hcp's was engaging the safety on the eclipse needle the safety fell off.The hcp was stuck with the needle.While one of the hcp's was engaging the safety on the eclipse needle the safety fell off.The hcp was stuck with the needle.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after use with bd eclipse¿ needle 25 g x 1 1/2 in.Single use sterile the safety mechanism detached and the hcp received a dirty needlestick injury.Hcp had bloodwork performed, patient will be getting bloodwork tested.The following information was provided by the initial reporter: it was reported by customer that while one of the hcp's was engaging the safety on the eclipse needle the safety fell off.The hcp was stuck with the needle.While one of the hcp's was engaging the safety on the eclipse needle the safety fell off.The hcp was stuck with the needle.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17199633
• Report Number: 8041187-2023-00296
• Device Sequence Number: 20275667
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: (01)30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K043397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 Model Number: 305767
• Device Catalogue Number: 305767
• Device Lot Number: 1301533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown