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

Catalog Number 368607

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for defective locking mechanism with the incident lot was observed.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 is aware of this product issue and further investigation has been conducted through a capa.As a result, corrective actions have been established and are in the process of being implemented.Based on evaluation of the customer photos, the customer¿s indicated failure mode for defective locking mechanism with the incident lot was observed.Further investigation activities have been conducted relating to this product issue and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this product issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.

Event Description

It was reported that needle safety feature on approximately 7 of the the bd eclipse¿ blood collection needle(s) with luer adapter, broke off of device, before use.There was no report of injury or medical intervention.

• 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: 7161454
• MDR Text Key: 96486022
• Report Number: 1024879-2017-01332
• 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
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 368607
• Device Lot Number: 7221954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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