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	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd eclipse¿ bd luer-lok¿ syringe with needle safety clip broke off.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: no samples and pictures were returned for investigation.There was no failure observed on the hub hook breakage and safety shield fall off/ break off test which was performed during out-going inspection.Dhr review could not be carried out as there was no lot number returned.Root cause description: root cause could not be determined as there is no sample returned for investigation.Rationale: capa# 56413 has been raised to address safety shield disengagement issue.If samples are received in the future the complaint will be re-opened and re-investigated.
Event or Problem Description
It was reported that bd eclipse¿ bd luer-lok¿ syringe with needle safety clip broke off.No serious injury or medical intervention was reported.

• 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: 8227888
• Report Number: 8041187-2018-00508
• Device Sequence Number: 1107007
• Product Code: FMI
• UDI-Device Identifier: 30382903057833
• UDI-Public: 30382903057833
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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 Catalogue Number: 305783
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/09/2019
• 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