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

Model Number	305891
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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 that the bd eclipse¿ needle experienced device damage while still considered operable, and needle and syringe separation.The following information was provided by the initial reporter: after administering the vaccine to client, i activated safety mechanism on the needle and as i pushed it closed, the cap and needle came off and felt the tip of the syringe break.No harm was done to me or the client but if the client was closer to me i feel that the glass that broke would have hit her in the arm.I believe it was the needle that caused the syringe to break - maybe it was put on too tight level of harm? -no effect - did not reach patient - detected before use or does not touch person during use who was affected? -no person affected unexpected or prolonged care? -no frequency of problem: -first time.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-06 h6: investigation summary: a device history record review was completed for provided lot number 2101021.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, we have been provided with the affected eclipse needle sample connected to a broken luer lock syringe.Through examination of the sample, no defects could be identified with the eclipse needle product.Based on the investigation results, it is not possible to identify an exact cause related to the eclipse needle manufacturing process for this reported incident.We can confirm that engagement force was measured during the manufacturing process for this product and all results were found to comply with specifications prior to the release of the product.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with the luer slip syringes.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced device damage while still considered operable, and needle and syringe separation.The following information was provided by the initial reporter: after administering the vaccine to client, i activated safety mechanism on the needle and as i pushed it closed, the cap and needle came off and felt the tip of the syringe break.No harm was done to me or the client but if the client was closer to me i feel that the glass that broke would have hit her in the arm.I believe it was the needle that caused the syringe to break - maybe it was put on too tight level of harm? -no effect - did not reach patient - detected before use or does not touch person during use.Who was affected? -no person affected.Unexpected or prolonged care? -no.Frequency of problem: -first time.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12866145
• Report Number: 3002682307-2021-00629
• Device Sequence Number: 3885249
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: 50382903058919
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: Other
• Device Expiration Date: 12/31/2025
• Device Model Number: 305891
• Device Catalogue Number: 305891
• Device Lot Number: 2101021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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