MAUDE Adverse Event Report: CAREFUSION, INC ACHIEVE BIOPSY NEEDLE; ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS

Catalog Number CA1815

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Follow up submission will be completed post investigation or if additional information becomes available.Actual device not received; only photo.

Event Description

During the mammography, after the puncture has been triggered, the needle got kinked in the breast of the patient.This was immediately apparent via the us device.When pulling out the bent needle, the angle was seen to be about 30 °.It can not be completely ruled out that metal splinters were released at the break point.Present were two doctors and one assistant.Add.Inf.Received (email attached) on (b)(6) 2018: a second diagnostic ultrasound was done.(no inf.About results provided) add.Inf.(b)(6) 2018 received initial reporter data (please see updated contact information) (b)(6) 2018 recieved photos (please see attachments) add.Inf.Received (b)(6) 2018 enclosed please find the feedback from the hospital: did the needle brake off in the chest? a: luckily the needle did not break off, but must have bent after insertion.When the punch biopsy was pulled out from the breast, the tip (channel for the tissue sample) was bent by almost 90 °.What were the consequences for the patient? a: unclear whether splinter material residues could be present.What significant remedial action was undertaken? a: ultrasound of the insertion site, informing the patient about the procedure.On (b)(6) 2018: per additional information received by the rcc on (b)(6) 2018: add.Inf.(b)(6) 2018: a second ultrasound of the site was done afterwards.(no information about results was provided)ccox.

Manufacturer Narrative

(b)(4).Our manufacturing quality engineer received one (1) photo of reported damaged product.During visual analysis of photo, failure mode was confirmed as the photo showed the tip of device to be bent as reported.Unfortunately, the quality engineer could not confirm defect through functional analysis as actual device was not returned for evaluation.They we able to perform a device history review of the reported lot manufactured on 12-feb-2016, which confirmed procedural and functional requirements needed for the product to be released were met.Although reported failure was confirmed through visual analysis, a root cause could not be determined as there was no physical or mechanical evidence to confirm or support manufacturing processes could be related to reported issue.That being said, no immediate actions will be proposed.Our bd quality team meets on a monthly basis to review customer complaint trends.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: ACHIEVE BIOPSY NEEDLE
• Type of Device: ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 7299186
• MDR Text Key: 101057330
• Report Number: 9680904-2018-00003
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• PMA/PMN Number: K141552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA1815
• Device Lot Number: 0000901887
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention