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

Catalog Number 368835

Device Problem Break (1069)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

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 when using the bd vacutainer® eclipse¿ signal¿ blood collection needle w/ holder there was non patient needle separation from the holder luer/adaptor/hub.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "when piercing the tube, the needle breaks loose from the sleeve.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-03-24.H.6.Investigation summary: bd received 1 sample and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for hub - holder separation was observed.The customer sample was evaluated by visual examination and the indicated failure mode for hub - holder separation with the incident lot was observed as a crack was seen on the holder.Additionally, 5 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 bd vacutainer tubes with water, and the issue of hub - holder separation was 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 hub - holder separation.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 w/ holder there was non patient needle separation from the holder luer/adaptor/hub.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "when piercing the tube, the needle breaks loose from the sleeve.".

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16482030
• MDR Text Key: 310793426
• Report Number: 9617032-2023-00233
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368835
• Device Lot Number: 2333774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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