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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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DEPUY MITEK LLC US INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Model Number 284508
Device Problems Crack (1135); Leak/Splash (1354); Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported by the sales rep that during a knee arthroscopy surgery on (b)(6) 2021, it was observed that the inflow tubing fms vue device tore on the pump wheel. According to the report, the device was leaking; and that it lost pressure in the knee while scoping. Another like device was used to complete the procedure with less than two minutes of delay. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
Manufacturer Narrative
Udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
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Brand NameINFLOW TUBING FMS VUE 24PK
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12760550
MDR Text Key280587145
Report Number1221934-2021-03265
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 Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284508
Device Catalogue Number284508
Device Lot Number3001593
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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