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

Catalog Number	305781
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 detachable needle there was an issue with foreign matter.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no sample or picture was return for investigation.Root cause could not be determined as there is no sample returned for investigation.During the review of dhr, there was no similar non- conformance found during out-going inspection.There was no quality notification raise for a similar non-conformance for the past one year.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 detachable needle there was an issue with foreign matter.There was no report of injury or medical intervention.

• Brand Name: BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8061903
• Report Number: 8041187-2018-00425
• Device Sequence Number: 2463908
• Product Code: FMI
• UDI-Device Identifier: 00382903057818
• UDI-Public: 00382903057818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• 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): 12/11/2018

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: 08/31/2022
• Device Catalogue Number: 305781
• Device Lot Number: 7237278
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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