MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305783
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
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 that bd eclipse¿ 3 ml bd luer-lok¿ syringe safety mechanism detached.This was discovered during use.The following information was provided by the initial reporter: material no: 305783, batch no: 9081645.It was reported that when nurse attempted to activate safety mechanism, the arm disengaged from the hinges and fell off.Nurse attempted to activate the safety mechanism and the arm disengaged from the hinges and fell off.
Additional Manufacturer Narrative
H.6.Investigation: one sample was received by our quality team for evaluation.Upon visual inspection there was no hub breakage or safety shield fall off; therefore, the incident can not be verified.A device history record review found no non- conformances associated with this issue during production of this batch.Based on the quality team's investigation the probable root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that bd eclipse¿ 3 ml bd luer-lok¿ syringe safety mechanism detached.This was discovered during use.The following information was provided by the initial reporter: material no: 305783, batch no: 9081645.It was reported that when nurse attempted to activate safety mechanism, the arm disengaged from the hinges and fell off.Nurse attempted to activate the safety mechanism and the arm disengaged from the hinges and fell off.

• Brand Name: BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9369906
• Report Number: 8041187-2019-00945
• Device Sequence Number: 14071887
• Product Code: FMI
• UDI-Device Identifier: 30382903057833
• UDI-Public: 30382903057833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 12/11/2019

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 Expiration Date: 02/28/2024
• Device Catalogue Number: 305783
• Device Lot Number: 9081645
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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