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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK FMSFLUID MANAGEMENT SYSTEM/INFLOW TUBING SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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DEPUY MITEK FMSFLUID MANAGEMENT SYSTEM/INFLOW TUBING SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Catalog Number 284504
Device Problem Pressure Problem (3012)
Patient Problem No Code Available (3191)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
The sales rep reported via phone call that the customer's fms tubing- irrigation tube set failed during a shoulder arthroscopy procedure due to the pressure on the pump dropping from 40 to 30 and all the way down to 9 while the tubing was in the patient¿s joint causing the joint to fill up and be distended and swollen. The case was completed by resetting the pump and changing the tube set. This tubing was used with a dup pump. The rep stated the patients swelling was able to be slightly relieved by massaging the fluid out, some fluid came out. The rep stated that this was a set-up error. The rep was present for the case right before the issue started with the devices. There was adverse patient consequence due to the swelling of the joint and excess fluid in the shoulder. There was a 5 minute time delay reported. The tubing was discarded so it will not be returned for evaluation. No replacement per rep.
 
Manufacturer Narrative
The complaint device is not available for a physical evaluation. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. At this point in time, no further action is warranted. However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed. Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Manufacturer Narrative
This follow up is being filed to correct the date to (b)(6) 2017. It was incorrectly reported on medwatch 1221934-2016-10576 follow up 1 as (b)(6) 2016.
 
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Brand NameFMSFLUID MANAGEMENT SYSTEM/INFLOW TUBING
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6214223
MDR Text Key63609749
Report Number1221934-2016-10576
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/01/2016,12/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2018
Device Catalogue Number284504
Device Lot Number1415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer12/01/2016
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/18/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/29/2016 Patient Sequence Number: 1
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