MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 110/8

Lot Number UNKNOWN

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.The patient's mother reported that the needle was missing from the infusion set and was taken to the hospital.Her blood glucose level at the time of the event was 488 mg/dl and she experienced drowsiness, nausea and was irritable.The patient had surgery the next day, during surgery a second needle was also found.Both the needles were removed successfully.No further information available.

• Brand Name: CONTACT¿DETACH
• Type of Device: CONTACT DETACH G29 110/8
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8559730
• MDR Text Key: 143380429
• Report Number: 3003442380-2019-01391
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006188
• UDI-Public: 05705244006188
• 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

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1