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

Model Number	305789
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types and 510k numbers reported to be involved.The information for the additional device type is as follows: medical device type: fmf, common device name: piston syringe, pma / 510(k)#: k941562.Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder based on the user area code and initial reporter facility.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.(b)(4).
Event or Problem Description
It was reported that after use with a bd eclipse¿ needle the safety mechanism detached.The following information was provided by the initial reporter: (4 of 5 complaints).It was reported that the shield fell off.The rn heard the shield click and it appeared to be engaged but then it disengaged/flipped down leaving the needle exposed.
Additional Manufacturer Narrative
Investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
Event or Problem Description
It was reported that after use with a bd eclipse¿ needle the safety mechanism detached.The following information was provided by the initial reporter: (4 of 5 complaints) it was reported that the shield fell off.- the rn heard the shield click and it appeared to be engaged but then it disengaged/flipped down leaving the needle exposed.

• Brand Name: BD ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10551638
• Report Number: 8041187-2020-00587
• Device Sequence Number: 19591371
• Product Code: FMI
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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 Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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