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

Catalog Number	305891
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the safety mechanism disconnected from the bd eclipse¿ safety needle when removing it from the packaging.The following information was provided by the initial reporter: "the safety device on a 1in needle was disconnected upon removing it from the packaging.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the safety mechanism disconnected from the bd eclipse¿ safety needle when removing it from the packaging.The following information was provided by the initial reporter: "the safety device on a 1in needle was disconnected upon removing it from the packaging.".
Additional Manufacturer Narrative
H6: investigation summary : to aid in the investigation of this incident, one (1) picture sample was provided for evaluation by our quality engineer team.Through examination of the picture, an eclipse needle was observed without the safety shield attached, the safety shield was loose next to the needle product.However, without the physical sample, we are unable to determine if any of the product components were damaged or if the shield just disengaged.Twenty (20) retained samples of the same lot number were obtained from the manufacturing facility for further examination.No signs of defect were observed in the safety mechanisms, and it was possible to properly activate each safety shield following the instructions for use (ifu).Without the affected physical sample, we are unable to identify an exact cause for this incident.A device history record review was completed for provided material number 305891 and lot number 2012005.The review did reveal one quality notification during the production process that be related to this reported issue.Each lot produced is tested for final safety shield activation prior to release.Lot number 2012005 was found in compliance with specifications before release.The assembly process has an inspection system in place which inspects all product for proper opening and activating of safety shields, rejecting any defects identified.Based on the provided feedback regarding how the safety shield disconnected upon removal from the package, it is possible that an issue with the safety shield assembly to the hub component occurred.

• 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: 16318799
• Report Number: 3002682307-2023-00018
• Device Sequence Number: 15427591
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 305891
• Device Lot Number: 2012005
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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