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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S T:30 INFUSION SET INSET 30

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UNOMEDICAL A/S T:30 INFUSION SET INSET 30 Back to Search Results
Model Number 7287
Device Problem Kinked (1339)
Patient Problems Cataract (1766); Coma (2417)
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow and leak. All test results were within specifications. The batch record # 5156782 was verified and it was found within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference samples from the same lot number. According to unomedical's traceability records, no relevant deviations were found. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). In (b)(6) 2016 a female diabetic patient went into a coma due to a blood glucose level of 1300-1400s mg/dl. The patient stated she discovered a kinked soft cannula. She was hospitalized for a week and was treated with iv fluids, customer does not remember the rest. The patient experienced permanent damage, since she has cataracts in her vision now. No further information available.
 
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Brand NameT:30 INFUSION SET
Type of DeviceINSET 30
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key6847591
MDR Text Key85087910
Report Number3003442380-2017-00011
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
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 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2017
Device Model Number7287
Device Lot Number5156782
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2017 Patient Sequence Number: 1
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