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

Model Number	305889
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 1900 bd eclipse¿ needles with smartslip¿ technology were blocked/clogged.The following information was provided by the initial reporter, translated from german to english: "we have received complaints from our customers that the eclipse safety cannulas are not permeable.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 8/18/2021 h.6.Investigation: a device history record review was completed for provided lot number 2012013.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, a shelf carton of eclipse needles was returned for evaluation by our quality engineer team.Twenty of the needles were selected for a thorough examination.The needles were assembled to a bd emerald syringe and liquid was able to be drawn up with no signs of leakage or defect.Based on the investigation results, an exact cause could not be determined for this reported incident.H3 other text : see h.10.
Event or Problem Description
It was reported that 1900 bd eclipse¿ needles with smartslip¿ technology were blocked/clogged.The following information was provided by the initial reporter, translated from german to english: "we have received complaints from our customers that the eclipse safety cannulas are not permeable.".

• Brand Name: BD ECLIPSE¿ NEEDLE WITH SMARTSLIP¿ TECHNOLOGY
• 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: 12331297
• Report Number: 3002682307-2021-00412
• Device Sequence Number: 2806212
• Product Code: FMI
• UDI-Device Identifier: 50382903058896
• UDI-Public: 50382903058896
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/29/2021

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: 11/30/2025
• Device Model Number: 305889
• Device Catalogue Number: 305889
• Device Lot Number: 2012013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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