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

Model Number	305760
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd eclipse needle with smartslip the needle detached from the syringe and leaked.There was no report of patient impact.The following information was provided by the initial reporter: ¿during fixing the safety-needle the lla got loose and finally detached from the tip.For this reason the solution leaked between the tip and the needle.The dose was not administered to the patient¿.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse needle with smartslip the needle detached from the syringe and leaked.There was no report of patient impact.The following information was provided by the initial reporter: ¿during fixing the safety-needle the lla got loose and finally detached from the tip.For this reason the solution leaked between the tip and the needle.The dose was not administered to the patient¿.
Event or Problem Description
It was reported while using bd eclipse needle with smartslip the needle detached from the syringe and leaked.There was no report of patient impact.The following information was provided by the initial reporter: ¿during fixing the safety-needle the lla got loose and finally detached from the tip.For this reason the solution leaked between the tip and the needle.The dose was not administered to the patient¿.
Additional Manufacturer Narrative
H6: investigation summary as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: BD ECLIPSE NEEDLE WITH SMARTSLIP
• 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 ; 8015296192
• MDR Report Key: 13560042
• Report Number: 3002682307-2022-00059
• Device Sequence Number: 14531400
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: 50382903057608
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/18/2022

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 Model Number: 305760
• Device Catalogue Number: 305760
• Device Lot Number: UNKNOWN
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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