MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 368609

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® eclipse¿ blood collection needle safety shield failed, and customer had a needlestick.The following information was provided by the initial reporter.The customer stated: "on (b)(6) 2022: "control blood draw done this morning.When securing the needle, the safety broke --> blood exposure accident.".

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing, each having their eclipse shields activated, and no issues were observed relating to defective locking mechanism as all samples met specifications.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 is unable to be confirmed for the indicated failure mode defective locking mechanism.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® eclipse¿ blood collection needle safety shield failed, and customer had a needlestick.The following information was provided by the initial reporter.The customer stated: "on (b)(6) 2022: "control blood draw done this morning.When securing the needle, the safety broke: blood exposure accident.".

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16055296
• MDR Text Key: 306241725
• Report Number: 1024879-2022-00742
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368609
• Device Lot Number: 2075983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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
• Patient Outcome(s): Required Intervention; Other