MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK UNIVERSAL CVC SECUREMENT DEVICE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3601CVC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by vygon, tidi's medical device distributor in italy: ¿the device in question was so attached to both the skin and the midline (catheter) that two operators were required to remove it without causing injury to the skin and displacing the cvc.It was also very difficult to reposition it correctly¿.
Additional Manufacturer Narrative
The complaint product was not available for evaluation.Therefore, this report is based solely on information provided by the reporter.There was no patient or caregiver injury reported.The instructions for use (ifu) contain the note: ¿use of an alcohol swab may help removal of securement device from the skin.¿ it is unknown if the end users are using any sort of solution to aid in the removal of the device.A copy of the current ifu was provided.Historical complaint data review identified other adhesive-related complaints for this part number and lot, also reported by vygon italy customers, for the opposite problem or failure of the device to hold on to the skin.The root cause was undetermined, but possible user error.A review of the device history record (dhrs) identified no nonconformances or other issues noted that could have contributed to the reported issue.At this time, it appears that the root cause is related to new users and device training problem.The reporter has been provided with a copy of the current instructions for use to be forwarded to the customer as necessary.No further corrective or preventive actions are required currently.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).

• Brand Name: GRIP-LOK UNIVERSAL CVC SECUREMENT DEVICE
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16526630
• Report Number: 2182318-2023-00012
• Device Sequence Number: 2644837
• Product Code: KMK
• UDI-Device Identifier: 00618125135011
• UDI-Public: 00618125135011
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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
• Device Model Number: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: 50111376
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown