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

Catalog Number	305891
Medical Device Problem Codes	Leak/Splash (1354); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ safety needle the needle and syringe could not connect properly and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: pushing together this new needle and the vaccine took lots of effort and in a final effort to push it onto the infanrix hexa syringe my grip slipped and the plunger was depressed causing vaccine spillage and subsequent wastage of vaccine.
Additional Manufacturer Narrative
Investigation summary a device history record review was completed for provided material number 305891 and lot number 2012007.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 retained samples of the reported lot were obtained for evaluation by our quality engineer team.The retained needle samples were assembled with a discardit 2ml syringe.No signs of defective hub connection were observed with any of the retained samples.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this reported incident.Engagement force is measured during manufacturing as part of the in-process inspections and final testing prior to product release.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes.
Event or Problem Description
It was reported while using bd eclipse¿ safety needle the needle and syringe could not connect properly and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: pushing together this new needle and the vaccine took lots of effort and in a final effort to push it onto the infanrix hexa syringe my grip slipped and the plunger was depressed causing vaccine spillage and subsequent wastage of vaccine.

• Brand Name: BD ECLIPSE¿ SAFETY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15556465
• Report Number: 3002682307-2022-00262
• Device Sequence Number: 20594581
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: 00382903058914
• 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): 10/27/2022

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 305891
• Device Lot Number: 2012007
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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