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

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CONTACT DETACH G29 110/8
• MDR Report Key: 8559730
• Report Number: 3003442380-2019-01391
• Device Sequence Number: 1667050
• Product Code: FPA
• UDI-Device Identifier: 05705244006188
• UDI-Public: 05705244006188
• Combination Product (Y/N): N
• PMA/510(K) Number: K041545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1