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

Catalog Number 368607

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: bd received photos from the customer facility for investigation.The photos were evaluated, and the customer's indicated failure mode for inability to activate safety shield 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 has initiated further investigation relating to this issue through a capa and potential causes from the manufacturing process have been identified.As a result, corrective actions have been established and are in the process of being implemented.Based on evaluation of the photos, the customer¿s indicated failure mode for inability to activate safety shield with the incident lot was observed.Further investigation activities have been conducted relating to this product issue and possible root causes from the manufacturing process have been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Bd has initiated further investigation through a capa.The investigation has identified possible root causes from the manufacturing process and corrective actions are in the process of being implemented.

Event Description

It was reported that the needle shield of a bd eclipse¿ blood collection needle with luer adapter failed, after use.It was reported that the needle ¿ended up bending resulting in a needle stick injury¿, which they reported to ¿the needlestick exposure line¿.No additional interventions were reported.

• 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: 7309775
• MDR Text Key: 101386356
• Report Number: 1024879-2018-00056
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686075
• UDI-Public: 50382903686075
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 368607
• Device Lot Number: 7230980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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