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 368836

Device Problem Break (1069)

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

Event Date 05/02/2023

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 that during use with bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder the safety shield broke off the needle.There was no report of patient or user impact.The following information was provided by the initial reporter, translated from french to english: the plastic broke when the needle was removed with the vacu body.

Manufacturer Narrative

The following fields were updated with additional information: d.10 device available for evalution? yes d.10 returned to manufacturer on: 06-sep-2023 h.6.Investigation summary: bd received 400 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for broken cannula hub was observed.Twenty (20) of the customer samples were chosen at random and evaluated by functional testing, each used to draw 6 vacutainer tubes with water, and the indicated failure mode for broken cannula hub with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes with water, and the issue of broken cannula hub 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 broken cannula hub.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that during use with bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder the safety shield broke off the needle.There was no report of patient or user impact.The following information was provided by the initial reporter, translated from french to english: the plastic broke when the needle was removed with the vacu body.

• 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 ; 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: 17066653
• MDR Text Key: 317660893
• Report Number: 9617032-2023-00666
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/06/2023

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: 368836
• Device Lot Number: 3024279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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