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

Catalog Number 368835

Device Problem Leak/Splash (1354)

Patient Problem Alteration In Body Temperature (2682)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for tube push off with the incident lot was not observed.Testing of the customer samples was performed and no tubes pushed off the needles.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.

Event Description

It was reported with the use of the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder there was an issue with tube do not stay at holders sleeve, it flies away.

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8176473
• MDR Text Key: 130892231
• Report Number: 9617032-2018-03136
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 368835
• Device Lot Number: 8149794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other