Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4503 USA IRRIGATION TUBE SETS PK/24 -SH; FMS TUBING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK 4503 USA IRRIGATION TUBE SETS PK/24 -SH; FMS TUBING Back to Search Results
Catalog Number 284504
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2014
Event Type  Injury  
Event Description
At the beginning of the procedure, the tank is filled.While the nurse is experienced, the problem persisted.She emptied the tank by removing the pressure sensor and the junction between the pipes for irrigation and the device 284504.Then plugging and screwing in the sensor, the problem persisted, but the tank is filling slowly.The nurse repeated the action.This increased operating time of 45 minutes.They finished the procedure with the same tubing.The procedure ended well without changing tubing, but wasting time and taking a health risk, disconnecting and reconnecting the junctions pump / patient.Increase operating time of 45 minutes.They finished the procedure with the same tubing.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Device eval: awaiting return.
 
Manufacturer Narrative
The complaint device is not being returned, therefore unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed 3 other similar complaints and 2 other dissimilar complaints for this lot of devices that were released to distribution in.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.
 
Event Description
At the beginning of the procedure, the tank is filled.While the nurse is experienced, the problem persisted.She emptied the tank by removing the pressure sensor and the junction between the pipes for irrigation and the device 284504.Then plugging and screwing in the sensor, the problem persisted, but the tank is filling slowly.The nurse repeated the action.This increased operating time of 45 minutes.They finished the procedure with the same tubing.The procedure ended well without changing tubing, but wasting time and taking a health risk, disconnecting and reconnecting the junctions pump / patient.Increase operating time of 45 minutes.They finished the procedure with the same tubing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4503 USA IRRIGATION TUBE SETS PK/24 -SH
Type of Device
FMS TUBING
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4244153
MDR Text Key5017354
Report Number1221934-2014-00497
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2014
Device Catalogue Number284504
Device Lot NumberD407001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/21/2014
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer10/21/2014
Date Manufacturer Received10/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-