MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE INTEGRATED HOLDER; SAFETY ENGINEERED BLOOD COLLECTION NEEDLE

Catalog Number 368835

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone: (b)(6).Initial reporter fax#: (b)(6).Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder had blood pooling in the hub, the phlebotomists removed the device from the patient, and the phlebotomist noticed that the blood leaked through the hub onto the patients arm.The phlebotomist threw out the packaging, so no lot number available.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE INTEGRATED HOLDER
• Type of Device: SAFETY ENGINEERED BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7365881
• MDR Text Key: 103524307
• Report Number: 9617032-2018-00058
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Catalogue Number: 368835
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other