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

Catalog Number	305788
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.There are two 510k's listed: k980987(syringe); k161170 (needle).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd eclipse¿ bd luer-lok¿ syringe with needle leaked.No reported medical interventions or serious injury.
Event or Problem Description
It was reported that a bd eclipse bd luer-lok syringe with needle leaked.No reported medical interventions or serious injury.
Additional Manufacturer Narrative
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: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.Correct catalog # 305788.Correct lot # 7269238.Correct expiration date 2022-09-30.Correct manufacture date 2017-09-26.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was received for investigation.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of leakage at luer connection with lot #7269238 regarding item #305788.Investigation conclusion: unable to determine a root cause.
Event or Problem Description
It was reported that a bd eclipse¿ bd luer-lok¿ syringe with needle leaked.No reported medical interventions or serious injury.

• Brand Name: BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7687790
• Report Number: 8041187-2018-00255
• Device Sequence Number: 11408175
• Product Code: FMI
• UDI-Device Identifier: 00382903057832
• UDI-Public: 00382903057832
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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): 08/17/2018

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: 09/30/2022
• Device Catalogue Number: 305788
• Device Lot Number: 7269238
• 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: 07/13/2018
• Supplement Report FDA Received Date: 07/31/2018; 08/31/2018
• 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