MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305759
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x5/8 safety mechanism failed it was reported by the customer that when using bd safety eclipse, the pink shield detached from the syringe when nurse went to activate the safety.The left the needle unshielded and at risk for a needlestick injury.Verbatim: when using bd safety eclipse, the pink shield detached from the syringe when nurse went to activate the safety.The left the needle unshielded and at risk for a needlestick injury.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of safety mechanism failure was confirmed upon inspection of the sample.Analysis of the sample showed the safety shield detached from the needle hub.The sample was subjected to inner diameter inspection of the hub hook and inspection for safety shield roundness.The outer diameter of the pivot rod was also inspected.All parameters were found to be within specification.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.The root cause could not be determined as the parameters were found within specification.Based on available information this is an isolated case and the probable cause could be attributed to user error during activation.
Event or Problem Description
Material#: 305759, batch#: 4023388.It was reported by the customer that when using bd safety eclipse, the pink shield detached from the syringe when nurse went to activate the safety.The left the needle unshielded and at risk for a needlestick injury.Verbatim: when using bd safety eclipse, the pink shield detached from the syringe when nurse went to activate the safety.The left the needle unshielded and at risk for a needlestick injury.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20276006
• Report Number: 2243072-2024-00985
• Device Sequence Number: 14301221
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)240219(17)290131(10)4023388
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Catalogue Number: 305759
• Device Lot Number: 4023388
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown