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

Catalog Number	305886
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.Investigation: a complaint history review could not be performed as no batch/lot number was made available for this reported event.A dhr review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable fmea/eura (p-eura rm432 rev.10 & a-eura rm846 rev.19) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.Root cause couldn't be determined due to unavailability of sample/lot number information.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd needle eclipse smartslip leaked at the hub/syringe connection.The following information was provided by the initial reporter: level of harm: no apparent harm.Incident details: received order to give patient at dose of prevenar 20 pneumococcal vaccine.Obtained vaccine from fridge.Connected the needle to the vaccine.Removed air and primed the needle without issue (no leakage noted at the time).When writer injected the vaccine, much of the vaccine leaked out between the needle and the vaccine.Unsure how much (if any patient received of the vaccine).Who was affected? patient.

• Brand Name: BD NEEDLE ECLIPSE SMARTSLIP
• Common Device Name: NEEDLES, HYPODERMIC
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21277446
• Report Number: 3002682307-2025-00010
• Device Sequence Number: 7908490
• Product Code: FMI
• UDI-Device Identifier: 50382903058865
• UDI-Public: (01)50382903058865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/18/2025

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: 305886
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown