MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305760
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3.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 while using the bd eclipse¿ needle the safety broke off and hcp was pricked with exposed needle.The following was translated from french to english: accident following a subcutaneous injection.After the injection, i put the safety in place, then when i was about to throw the needle into the darsi, the safety came off and i accidentally pricked the thumb of my right hand.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2301004.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples of the same lot number were obtained from the manufacturing facility.The retained samples were evaluated, and it was possible to activate the safety mechanism without defect by following the instructions for use.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this reported incident.Each lot produced is tested for safety shield activation prior to release.The assembly process has a system in place which inspects all product for proper opening and activation of the safety shield.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Additional Manufacturer Narrative
Correction: the f code has been updated to 'insufficient information' to align with the available information in the complaint record.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17785872
• Report Number: 3002682307-2023-00285
• Device Sequence Number: 17861561
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: 00382903057603
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100209
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2024

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: 305760
• Device Lot Number: 2301004
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 01/04/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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