MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE S/T 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305760
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
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 needle eclipse s/t 25x5/8 rb had broken safety mechanisms.The following information was provided by the initial reporter: "twice today a nurse went to click the safety device and both times it broke off or fell right off the hub of the needle.".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 2011006.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 retained samples were obtained for further evaluation.The retained samples were inspected and no defects were identified.It was possible to activate the safety mechanism for each sample 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 incident.
Event or Problem Description
It was reported 2 bd needle eclipse s/t 25x5/8 rb had broken safety mechanisms.The following information was provided by the initial reporter: "twice today a nurse went to click the safety device and both times it broke off or fell right off the hub of the needle.".

• Brand Name: BD NEEDLE ECLIPSE S/T 25X5/8 RB
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12724853
• Report Number: 3002682307-2021-00583
• Device Sequence Number: 3706795
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: 50382903057608
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 305760
• Device Catalogue Number: 305760
• Device Lot Number: 2011006
• 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: 10/01/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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
• Patient Sex: Unknown