MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305762
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of needles eclipse 23x1 rb experienced the needle and syringe separating/spinning out after use.The following information was provided by the initial reporter: material no: 305762, batch no: unknown.Event description: user facility recently reported an event involving bd's eclipse needle.Team members reported the following: on (b)(6) 2019 after a flu shot was administered to a patient, xxx (cma) closed the bd eclipse needle safety and it locked and then dislodged from the syringe, hitting the wall.Per customer's response to information request, the catalog number and possible lot number was provided.Customer confirmed that the needle/hub separated from the syringe and that the needle point remained covered by the safety.Unused samples from possible lot are available for investigation.
Additional Manufacturer Narrative
H.6.Investigation: ten representative samples were received by our quality team for evaluation.Upon visual inspection to check on the eclipse hub.No damage on the eclipse hub collar and thread area of the hub were observed; therefore, the incident could not be verified.All ten samples were also manually connected to a 3ml luer lock syringe and the safety shield were then activated.All samples observed to stay intact with the syringes and did not display any signs of loose / fall off of the eclipse part after activation.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the investigation, no root cause could be established due to the samples passing all testing.
Event or Problem Description
It was reported that an unspecified number of needles eclipse 23x1 rb experienced the needle and syringe separating/spinning out after use.The following information was provided by the initial reporter: material no: 305762, batch no: unknown event description: user facility recently reported an event involving bd's eclipse needle.Team members reported the following: on (b)(6) 2019 after a flu shot was administered to a patient, xxx (cma) closed the bd eclipse needle safety and it locked and then dislodged from the syringe, hitting the wall.Per customer's response to information request, the catalog number and possible lot number was provided.Customer confirmed that the needle/hub separated from the syringe and that the needle point remained covered by the safety.Unused samples from possible lot are available for investigation.

• Brand Name: NEEDLE ECLIPSE 23X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9539972
• Report Number: 8041187-2019-01059
• Device Sequence Number: 11540164
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305762
• Device Catalogue Number: 305762
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other