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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4503 USA IRRIGATION TUBE SETS PK/24 -SH; FMS TUBING
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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 11/26/2014
Event Type  Injury  
Event Description
No aspiration / circulation.During the operation, the tubing is filled without emptying.They finished the procedure without the pump.Then at the end of procedure; they made a new test outside of the patient with a new manifold and the problem is again reproduced.Associated med watch # 1221934-2014-00557.
 
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.Awaiting return.
 
Manufacturer Narrative
This is a follow up report to document device return.A final report will be filed once the device has been investigated.In process.
 
Event Description
No aspiration / circulation.During the operation, the tubing is filled without emptying.They finished the procedure without the pump.Then at the end of procedure; they made a new test outside of the patient with a new manifold and the problem is again reproduced.Associated med watch # 1221934-2014-00557.
 
Manufacturer Narrative
The complaint tube set was received and evaluated by r&d.Visual observation reveals no anomalies with the returned device.The device passed the air leak test successfully.No leak below fill chamber or on the luer-lock joint was observed.Therefore, the reported failure cannot be confirmed.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 as related the reported problem, and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 11 other similar complaints and one other dissimilar complaint for this lot of (b)(4) devices that were released to distribution.7 of the similar complaints were from the same facility and did not come back for evaluation.A root cause for the user to have experienced this failure cannot be determined.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.
 
Event Description
No aspiration / circulation.During the operation, the tubing is filled without emptying.They finished the procedure without the pump.Then at the end of procedure; they made a new test outside of the patient with a new manifold and the problem is again reproduced.The following additional information was received from our affiliate and summarized by a mitek complaint analyst; the tube set was set up correctly, and there was no kink in the tubing.The tubing was not collapsed, and there was no problem with the pinch valve.The procedure was extended over thirty minutes due to the problem with the complaint device.The procedure was completed without use of the pump, using gravity.Associated med watch # 1221934-2014-00557.
 
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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
david primmerman
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4362974
MDR Text Key20126526
Report Number1221934-2014-00556
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,Followup
Report Date 11/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2015
Device Catalogue Number284504
Device Lot NumberD331104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/27/2014
Device Age12 MO
Event Location Hospital
Date Report to Manufacturer11/27/2014
Date Manufacturer Received11/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2013
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;
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