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

Model Number 368650

Device Problems Inability to Auto-Fill (1044); Complete Blockage (1094); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® eclipse¿ blood collection needle w/ pre-attach holder there was tube push off nonpatient end needle, blood leakage or other sample leakage from the device, and complete blockage.The following information was provided by the initial reporter.The customer stated: "filter fills with blood and needle seems occluded, leakage and tubes being pushed off.".

Manufacturer Narrative

Corrected information has been provided please see changes below: b.5.Event or problem: bd vacutainer® eclipse¿ signal¿ blood collection needle.D.1.Medical device brand name: bd vacutainer® eclipse¿ signal¿ blood collection needle.D.2.Common device name: blood specimen collection device.D.2 medical device type: jka.D.3.Medical device manufacturer: becton, dickinson and company (bd).D.4.Medical device catalog #: 368837.D.4.Unique identifier (udi) #: (b)(4).D.4.Medical device expiration date: 2025-03-31.G.1.Manufacturing location: becton, dickinson and company (bd).G.5.Pma/510k: na.H.4.Device manufacture date: 2022-03-03.H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for sleeve leakage was observed.The failure modes of clogged cannula and tube push off could not be seen in the photos.Additionally, 5 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 tubes, and the issues of sleeve leakage, clogged cannula, and tube push off were not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode sleeve leakage.This complaint has been unconfirmed for the failure modes of clogged cannula and tube push off.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® eclipse¿ signal¿ blood collection needle there was tube push off nonpatient end needle, blood leakage or other sample leakage from the device, and complete blockage.The following information was provided by the initial reporter.The customer stated: "filter fills with blood and needle seems occluded, leakage and tubes being pushed off.".

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth SC ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth SC ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14991928
• MDR Text Key: 296177717
• Report Number: 1024879-2022-00359
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 368650
• Device Catalogue Number: 368837
• Device Lot Number: 2062121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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