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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT

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AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT Back to Search Results
Model Number 1002825
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. It was reported that the patient's infusion set's tubing connector was not attached to the tubing at all. No further information available.
 
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Brand NameAUTOSOFT 30
Type of DeviceUNO INSET 30 60/13 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12947868
MDR Text Key281842614
Report Number3003442380-2021-00790
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K061374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002825
Device Lot Number5349819
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided

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