MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305766
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 2 bd eclipse¿ needles had safety mechanisms that detached, resulting in needle sticks.The following information was provided by the initial reporter: "the safety cap part of the needle, used to close the needle before it is discarded, has snapped off while 2 different staff members were trying to close them resulting in a contaminated needle stick.".
Additional Manufacturer Narrative
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 2 bd eclipse¿ needles had safety mechanisms that detached, resulting in needle sticks.The following information was provided by the initial reporter: "the safety cap part of the needle, used to close the needle before it is discarded, has snapped off while 2 different staff members were trying to close them resulting in a contaminated needle stick.".
Additional Manufacturer Narrative
H.6.Investigation: seventy-nine (79) representative samples were received by our quality team for evaluation.The samples were subjected to eclipse safety shield inspection to check for hub hook breakage or safety shield fall off / break off.All samples passed the eclipse safety shield inspection.The samples were subjected to activation / locking force test.All samples passed the activation / locking force test.A review of the internal manufacturing device records and raw material history files for the reported lot number 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.
Event or Problem Description
It was reported 2 bd eclipse¿ needles had safety mechanisms that detached, resulting in needle sticks.The following information was provided by the initial reporter: "the safety cap part of the needle, used to close the needle before it is discarded, has snapped off while 2 different staff members were trying to close them resulting in a contaminated needle stick.".

• Brand Name: BD ECLIPSE¿ NEEDLE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12957384
• Report Number: 8041187-2021-01027
• Device Sequence Number: 5409561
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: 30382903057666
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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): 12/09/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 305766
• Device Catalogue Number: 305766
• Device Lot Number: 1118955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: Other
• Patient Sex: Unknown