MAUDE Adverse Event Report: CAREFUSION/BD ABG MICRO KIT 1ML 25 GAUGE 5/8" SL KIT; KIT, SAMPLING, ARTERIAL BLOOD

Catalog Number 9025510

Device Problem Disconnection (1171)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion has been notified by the customer that the suspect device/component is not available for evaluation.It has been confirmed the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with device.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported "we are having major issues with the needle falling off in the patients arm".Customer states there were no injuries.The needle disconnected from the hub customer stated the needle was removed manually from the patient and the patient did not require any additional first aid.

Manufacturer Narrative

Unfortunately the sample used during this reported incident was not available for evaluation it was disposed of by the end-user; therefore the failure mode could not be confirmed at this time.The device history record was reviewed for the reported lot number and no issues related to the reported failure mode were found.The product was manufactured, inspected, and released in accordance with carefusion/(b)(4) internal procedures.The needle is not manufactured by carefusion/(b)(4), this is a supplied component.Carefusion/(b)(4) will continue to do incoming inspections to this product per policy.A supplier corrective action request has been initiated to further investigate into this reported failure mode.Carefusion/(b)(4) will continue to work with the supplier to determine a root cause for this customers report.

• Brand Name: ABG MICRO KIT 1ML 25 GAUGE 5/8" SL KIT
• Type of Device: KIT, SAMPLING, ARTERIAL BLOOD
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5982073
• MDR Text Key: 55790010
• Report Number: 8030673-2016-00233
• Device Sequence Number: 1
• Product Code: CBT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9025510
• Device Lot Number: 0000974108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• 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