MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ 3 ML 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 that bd eclipse¿ 3 ml bd luer-lok¿ syringe with needle leaked at the luer connection point.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd eclipse¿ 3 ml bd luer-lok¿ syringe with needle leaked at the luer connection point.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was received for investigation.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage at luer connection with lot #7293225 regarding item #305783.Investigation conclusion: unable to determine a root cause.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device single use?: no.Device returned to manufacturer: no.
Event or Problem Description
It was reported that bd eclipse¿ 3 ml bd luer-lok¿ syringe with needle leaked at the luer connection point.No serious injury or medical intervention was reported.

• Brand Name: BD ECLIPSE¿ 3 ML 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: 7697266
• Report Number: 8041187-2018-00264
• Device Sequence Number: 18982654
• 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): 08/16/2018

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: 10/31/2022
• Device Catalogue Number: 305783
• Device Lot Number: 7293225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018; 06/15/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/05/2018
• 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