MAUDE Adverse Event Report: CAREFUSION, INC TEMNO EVOLUTION COAXIAL; MODIFICATION TO TEMNO BIOPSY NEEDLES

Catalog Number CTT2015

Device Problems Positioning Failure (1158); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Follow up submission will be completed post investigation or if additional information becomes available.

Event Description

Customer called to report that on (b)(6) 2018 while performing a lung biopsy of the upper lobe left side on (b)(6) male patient , the product failed to deploy and was stuck.The doctor performing the procedure had to use a laceration kit to remove the product from the patient.While speaking with the customer she reported that x-ray was used to confirm the product was removed entirely from patient.Per facility representative no additional information will be provided.

Manufacturer Narrative

(b)(4) our manufacturing quality engineer received one (1) sample from lot #0001141884 for evaluation.During visual inspection the device was noted to be twisted and deformed therefore, not allowing functional testing to be performed.Therefore, the reported failure mode could not be confirmed.Additionally, an internal review of the history files was completed for the reported lot number manufactured on 16-aug-2017 confirming procedural and functional requirements needed for the product to be released were met.As reported failure mode could not be confirmed during analysis, a root cause was not determined an immediate action will not be proposed.The failure mode will be entered into the complaint management system and will be tracked/trended for any additional similar failure modes.Customer complaint trends are evaluated on a monthly basis during our quality team meeting.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: TEMNO EVOLUTION COAXIAL
• Type of Device: MODIFICATION TO TEMNO BIOPSY NEEDLES
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7303396
• MDR Text Key: 101237440
• Report Number: 9680904-2018-00004
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/16/2022
• Device Catalogue Number: CTT2015
• Device Lot Number: 0001141884
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 98