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

Catalog Number	305760
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/02/2023
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 the bd eclipse¿ needle safety mechanism detached and the needle pricked the nurse's hand.The following information was provided by the initial reporter: the department reports that the subcutaneous needle securing element detached from the rest of the needle when securing the needle after injection of the product daratumumab (monoclonal antibody by subcutaneous route).The needle twisted, pierced the individual protective glove and pricked the nurse's hand.
Additional Manufacturer Narrative
H6: investigation summary: 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 for evaluation.The samples were inspected and no defects were observed with the safety mechanisms.It was possible to activate the safety shield by following the instructions for use.Based on the investigation results, an exact cause could not be determined for the reported incident.H3 other text : see h10.
Event or Problem Description
It was reported that the bd eclipse¿ needle safety mechanism detached and the needle pricked the nurse's hand.The following information was provided by the initial reporter: the department reports that the subcutaneous needle securing element detached from the rest of the needle when securing the needle after injection of the product daratumumab (monoclonal antibody by subcutaneous route).The needle twisted, pierced the individual protective glove and pricked the nurse's hand.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17038172
• Report Number: 3002682307-2023-00144
• Device Sequence Number: 6394082
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: (01)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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 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: 05/09/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/27/2023
• 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