MAUDE Adverse Event Report: CAREFUSION, INC TEMNO NEEDLE BIOPSY COAXIAL 18G X 11CM; BIOPSY NEEDLE KIT

Model Number CT1811

Device Problem Physical Property Issue (3008)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information becomes available a follow up emdr will be submitted.Needle stick/puncture (b)(4).Physical property issue (b)(4).

Event Description

Customer reported via email: upon disengaging the biopsy mechanism to expose the specimen, the spring loaded two part handle broke apart and the spring shot out causing the blade to lunge forward sticking the cytologytech.The device handle broke into several pieces.Per customer, no additional information available.

Manufacturer Narrative

(b)(4) a review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.Lot #0000909688 was manufactured on 07-mar-2016.Conclusion(s): customer ¿ sample not returned: based on the investigation results, a probable root cause could not be identified for the reported failure mode since samples were not returned for evaluation.This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.

• Brand Name: TEMNO NEEDLE BIOPSY COAXIAL 18G X 11CM
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo ; DR
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6350102
• MDR Text Key: 68047810
• Report Number: 9680904-2017-00100
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CT1811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Date Device Manufactured: 03/07/2016
• 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