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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT

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TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT Back to Search Results
Model Number 1002833
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. The patient's mother reported that on (b)(6) 2021, her (b)(6) year-old son's infusion set's tubing detached/broken at site connector. At the time of the event, his blood glucose level was 200 mg/dl, after his breakfast with high sugar. Moreover, the patient's mother assisted him to give a correction bolus via pump. Further, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameTRUSTEEL
Type of DeviceUNO CONTACT DETACH G29 60/6TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12932056
MDR Text Key281738462
Report Number3003442380-2021-00781
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002833
Device Lot Number5314359
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided

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