MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE 21G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305895
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
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 hypodermic needle with protection device 21g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: when you put the bd eclipse g21 needles on the syringes, liquid leaks out.
Event or Problem Description
It was reported while using bd eclipse hypodermic needle with protection device 21g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: when you put the bd eclipse g21 needles on the syringes, liquid leaks out.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 16-feb-2023.H6: investigation summary a device history record review was completed for provided material number 305895 and lot number 2202015.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, one (1) unopened shelf carton of eclipse needles was returned for evaluation by our quality engineer team.Twenty (20) needle samples from the shelf carton were randomly selected for a thorough examination.The needles were assembled with a bd discardit 2ml syringe and no signs of defective hub connection or leakage were detected.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for the reported incident.The smartslip technology has been introduced to help ensure a secure connection is made with luer slip syringes.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.

• Brand Name: BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE 21G
• 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: 16376344
• Report Number: 3002682307-2023-00022
• Device Sequence Number: 12331943
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• 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): 05/09/2023

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: 305895
• Device Lot Number: 2202015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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