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

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.

• Brand Name: T:30 INFUSION SET
• Type of Device: INSET 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 Key: 6847591
• MDR Text Key: 85087910
• Report Number: 3003442380-2017-00011
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• 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 Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2017
• Device Model Number: 7287
• Device Lot Number: 5156782
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening