MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE

Catalog Number	305783
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 with the use of the bd eclipse¿ bd luer-lok¿ syringe with needle there was an issue with leakage.It was stated by the consumer ¿there was leaking at the luer lock connection when pushing meds into the line.¿ there was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was received for investigation.Dhr review shows eclipse batch # 7362021 had no abnormality or quality notifications during production.Maintenance, calibration and equipment records showed no abnormality that could have influenced the issue.If samples are received in the future the complaint will be re-opened and re-investigated.
Event or Problem Description
It was reported with the use of the bd eclipse¿ bd luer-lok¿ syringe with needle there was an issue with leakage.It was stated by the consumer ¿there was leaking at the luer lock connection when pushing meds into the line.¿ there was no report of injury or further medical intervention.
Event or Problem Description
It was reported with the use of the bd eclipse¿ bd luer-lok¿ syringe with needle there was an issue with leakage.It was stated by the consumer ¿there was leaking at the luer lock connection when pushing meds into the line.¿ there was no report of injury or further medical intervention.

• Brand Name: BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7655771
• Report Number: 8041187-2018-00228
• Device Sequence Number: 13833954
• Product Code: FMI
• UDI-Device Identifier: 30382903057833
• UDI-Public: 30382903057833
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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: 11/30/2022
• Device Catalogue Number: 305783
• Device Lot Number: 7362021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/15/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/02/2018
• 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