MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

Catalog Number 368610

Device Problems Detachment Of Device Component (1104); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The lot number 7243784 was reported, however was not found for the reported catalog number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle safety detached from a bd eclipse¿ blood collection needle with luer adapter, leaving the used needle exposed and contributed to a dirty needle stick received by the user.The needle stick was washed and the user "reported to occupational health".

Manufacturer Narrative

Correction: after further evaluation, it has been determined that this complaint is a duplicate of a previously submitted complaint: mfr report # 1024879-2017-01288.Patient identifier (b)(6).

• Brand Name: BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7222806
• MDR Text Key: 98411864
• Report Number: 1024879-2018-00039
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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: Phlebotomist
• Device Catalogue Number: 368610
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 01/29/2018
• 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
• Patient Outcome(s): Required Intervention