MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ SAFETY NEEDLE WITH BD LUER-LOKTM SYRINGE; BLOOD COLLECTION SET

Catalog Number	305784
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/03/2018
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 and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that while using a bd eclipse¿ safety needle with bd luer-loktm syringe, it leaked between the thread of the syringe and the needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: 50 pcs representative samples were received and 30 pcs were subjected to leak test.All the samples passed the test.Our quality engineer inspected the returned units and could not identify any manufacturing related defects.As a result, the root cause of the reported issue could not be determined.A device history record review showed no abnormality during production that could have influenced the issue.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD ECLIPSE¿ SAFETY NEEDLE WITH BD LUER-LOKTM SYRINGE
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7436944
• Report Number: 8041187-2018-00110
• Device Sequence Number: 1252452
• Product Code: JKA
• UDI-Device Identifier: 30382903057840
• UDI-Public: 30382903057840
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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
• Report Date (Section B): 05/02/2018

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: 305784
• Device Lot Number: 7269201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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