MAUDE Adverse Event Report: CAREFUSION, INC COAXIAL TEMNO EVOLUTION; BIOPSY NEEDLES & TRAYS

Catalog Number CTT1411

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up submission will be done upon completion of carefusion's investigation or additional information becomes available.

Event Description

Ctt1411 packaging not sealed when removed from base.Only 1 item in case that was unsealed.The needles are stored hanging in the ir suite.

Manufacturer Narrative

(b)(4) our manufacturing quality engineer received one (1) sample in its original unopened package from lot #0001135971 for evaluation.During visual evaluation, the quality engineer identified openings throughout the blister, therefore failure mode was confirmed.An internal review of the history files was completed for the reported lot number 0001135971, manufactured on 02-oct-2017 confirming procedural and functional requirements needed for the product to be released were met.Most probable root cause of reported failure is considered to be the package sealing stage of the manufacturing process as opportunities were found in the peel strength procedure and work instruction.We have since opened a corrective action plan to prevent this issue from recurring.The failure mode will be entered into the complaint management system and will be tracked/trended for any similar failure modes.Customer complaint trends are evaluated on a monthly basis during our quality team meeting.

• Brand Name: COAXIAL TEMNO EVOLUTION
• Type of Device: BIOPSY NEEDLES & TRAYS
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 7333950
• MDR Text Key: 102588328
• Report Number: 9680904-2018-00006
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K024120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: CTT1411
• Device Lot Number: 0001135971
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other