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

Catalog Number	305891
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
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 the bd eclipse¿ safety needle clogged.The following information was provided by the initial reporter: needle was attached to syringe without any obvious deformity, writer able to prime syringe.Attempted to inject client with vaccine, plunger would not inject despite firm pressure applied.
Event or Problem Description
It was reported that the bd eclipse¿ safety needle clogged.The following information was provided by the initial reporter: needle was attached to syringe without any obvious deformity, writer able to prime syringe.Attempted to inject client with vaccine, plunger would not inject despite firm pressure applied.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 305891 and batch number 2102001.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 reported lot were obtained from the manufacturing facility.The needles were assembled with a discardit 2ml syringe and liquid went through the needle cannula normally with no signs of occlusion observed.Needles are inspected for occlusion as part of the in-process inspection after assembly.In certain circumstances, the drug used can become deposited within the cannula, causing the needle to block due to crystallization.Occlusion is most likely to occur if the drug remains in the needle for an extended period of time.

• 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: 16554859
• Report Number: 3002682307-2023-00062
• Device Sequence Number: 19560001
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: 00382903058914
• 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): 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 Expiration Date: 01/31/2026
• Device Catalogue Number: 305891
• Device Lot Number: 2102001
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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