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

Catalog Number	305891
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
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 that vaccine medication leaked out of the bd eclipse¿ safety needle during use due to a bad connection.The following information was provided by the initial reporter: "these are the orange needles with item number 305891 and lot number 2211001.These have a bad connection, resulting in vaccine regularly running down the needle.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 12-apr-2023.H6: investigation summary a device history record review was completed for provided material number 305891 and batch number 2211001.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.To aid in the investigation of this issue, an entire box of eclipse needles was returned for evaluation by our quality engineer team.Twenty (20) random needles were selected for thorough examination.The needles were assembled with a bd discardit 2ml syringe; however, no signs of defective connection or leakage were observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.H3 other text : see h10.
Event or Problem Description
It was reported that vaccine medication leaked out of the bd eclipse¿ safety needle during use due to a bad connection.The following information was provided by the initial reporter: "these are the orange needles with item number 305891 and lot number 2211001.These have a bad connection, resulting in vaccine regularly running down the needle.".

• Brand Name: BD ECLIPSE¿ SAFETY 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16585576
• Report Number: 3002682307-2023-00074
• Device Sequence Number: 19257331
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: 00382903058914
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/15/2023

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: Other
• Device Catalogue Number: 305891
• Device Lot Number: 2211001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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