MAUDE Adverse Event Report: SURE-T®; CONTACT DETACH G29 80/8

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 (b)(6).The patient reported that the needle broke and remained in the body.Reportedly, surgery was needed to remove it.The pack of infusion sets was replaced.No further information available.

• Brand Name: SURE-T®
• Common Device Name: CONTACT DETACH G29 80/8
• MDR Report Key: 8263603
• Report Number: 3003442380-2019-00163
• Device Sequence Number: 1318739
• Product Code: FPA
• UDI-Device Identifier: 05705244006010
• UDI-Public: 05705244006010
• 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: 12/04/2018
• Initial Report FDA Received Date: 01/21/2019
• Patient Sequence Number: 1