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

Lot Number	5232791
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that the needle got pulled out of the body accidently and the patient had to stick the needle back in.It was also reported that the infusion set tubing came apart while changing shirts.The site location was on the patient's right side and the pump was worn on the patient's hip on right side or center of the body.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient was unsure whether there was stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.
Event or Problem Description
On 08-nov-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 set) showed that the all the test were within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that the needle got pulled out of the body accidently and the patient had to stick the needle back in.It was also reported that the infusion set tubing came apart while changing shirts.The site location was on the patient's right side and the pump was worn on the patient's hip on right side or center of the body.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient was unsure whether there was stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 80/8 PCC
• MDR Report Key: 8342385
• Report Number: 3003442380-2019-00566
• Device Sequence Number: 16721272
• Product Code: FPA
• UDI-Device Identifier: 05705244006072
• UDI-Public: 05705244006072
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/01/2021
• Device Lot Number: 5232791
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 11/08/2019
• Patient Sequence Number: 1