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

Catalog Number 368607

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

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 the safety shield fell off on a bd eclipse¿ blood collection needle with luer adapter when removing the needle shield prior to use.No report of injury or medical intervention.

Manufacturer Narrative

Summary - bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Conclusion - as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Root cause - although no samples or photos were available for evaluation, bd has initiated further investigation through a capa.The capa has identified the most likely root causes and corrective actions are in the process of being implemented.

• Brand Name: BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION SET
• 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: 7097987
• MDR Text Key: 94870786
• Report Number: 1024879-2017-01232
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686075
• UDI-Public: 50382903686075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 368607
• Device Lot Number: 5345723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• 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): Other