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

Model Number	305762
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/03/2022
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 that the safety shield failed to completely cover the bd eclipse¿ needle after use, leaving the tip exposed and resulting in a dirty needlestick.Blood work was performed per protocol.The following information was provided by the initial reporter: "i had an employee who experienced a needlestick injury as a result of a safety shield defect.She explained that she both heard and felt the "click" of the safety shield, but still poked herself.When she took a closer look at the needle after she had been poked, she noticed that though the safety shield had been applied, the tip of the needle was still exposed and had not been "clicked in", the shield was only protecting the base of the needle." "the employee was bleeding and, as this was a used/dirty needle, she had to flush the site with water and apply a bandage.She also had to get her bloodwork done to check for any communicable diseases.".
Additional Manufacturer Narrative
H.6.Investigation: four representative samples were received by our quality team for evaluation.The representative samples were subjected to visual inspection.No deformation or damage was observed on the eclipse hub and safety shield.No breakage was observed on the safety lock pin.The samples were subjected ot activation / locking force testing, and all samples passed this testing.The activated samples were then subjected to inspection to check for exposed cannula tip.For all samples, the cannula was observed to fit into the safety lock pin with no exposed cannula tip.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 that the safety shield failed to completely cover the bd eclipse¿ needle after use, leaving the tip exposed and resulting in a dirty needlestick.Blood work was performed per protocol.The following information was provided by the initial reporter: "i had an employee who experienced a needlestick injury as a result of a safety shield defect.She explained that she both heard and felt the "click" of the safety shield, but still poked herself.When she took a closer look at the needle after she had been poked, she noticed that though the safety shield had been applied, the tip of the needle was still exposed and had not been "clicked in", the shield was only protecting the base of the needle." "the employee was bleeding and, as this was a used/dirty needle, she had to flush the site with water and apply a bandage.She also had to get her bloodwork done to check for any communicable diseases.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13869375
• Report Number: 8041187-2022-00143
• Device Sequence Number: 14582701
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 305762
• Device Catalogue Number: 305762
• Device Lot Number: 9308070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2019
• 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