MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 60/6

Lot Number 5112006

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that patient's blood glucose level increased, and the site was removed, noticed that the cannula could not be found.A new site was inserted to bring down patient's blood glucose level.The patient was taken to the emergency room to determine if the cannula was broken off under the skin and underwent x-rays showing the site was broken off under the skin.Patient's blood glucose level was 326 mg/dl when arrived at the emergency room and received tylenol via intravenous route as corrective treatment.The emergency staff attempted to remove the cannula however they were unsuccessful.After spending 3 hours in emergency room the patient was subsequently hospitalized and received antibiotics and fluid via intravenous route as corrective treatment.Prior to hospitalization, the patient took a bolus.The cannula was surgically removed, and the patient received 7 stitches.The infusion set was in use for 2 days.The patient was hospitalized for 9 days.No further information available.

• Brand Name: CONTACT¿DETACH
• Type of Device: CONTACT DETACH G29 60/6
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8535386
• MDR Text Key: 142613980
• Report Number: 3003442380-2019-01143
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244003293
• UDI-Public: 05705244003293
• Combination Product (y/n): N
• PMA/PMN Number: K041545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/15/2020
• Device Lot Number: 5112006
• Initial Date Manufacturer Received: 12/17/2016
• Initial Date FDA Received: 04/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1