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	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd needleeclipse smartslip leaked.The following information was provided by the initial reporter: needle failure: leaked while administering medication unable to administer xxx as required due to leaky needle.Level of harm: no apparent harm - reached patient/person, inconvenient.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305886 and lot number 2101009.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 needle samples of the same lot number were obtained from the manufacturing facility.The retained samples were assembled with a bd discardit 2ml syringe.No signs of defective hub connection or leakage were observed.Based on the investigation results, an exact cause related to the manufacturing process could not be determined.Engagement force is measured during the manufacturing process as part of the in-process inspections and final testing prior to release.This lot was found to be within specifications.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes (the most common syringe design in europe).We recommend that the user closely follow the instructions for use, which are unique in recommending that the user push firmly when attaching the needle to the syringe and to be sure that the clip is activated.The clip acts as an indicator that a suitable force has been applied to engage the needle hub.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• 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: 20330193
• Report Number: 3002682307-2024-00196
• Device Sequence Number: 9574066
• Product Code: FMI
• UDI-Device Identifier: 50382903058865
• UDI-Public: (01)50382903058865(11)210107(17)251231(10)2101009
• 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: Foreign,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 305886
• Device Lot Number: 2101009
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown