MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK PICC/CVC SECUREMENT DEVICE, STERILE, MEDIUM; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3601CVC
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device return is expected, but not yet received.Therefore, this report is based solely on information provided by the reporter.There was no patient or caregiver injury reported.It was reported that they are having difficulty with removal of the device due to the device reportedly being too sticky.The event description states that the users are utilizing alcohol to aid in device removal per the instructions for use (ifu).The ifu contains the note: "use of an alcohol swab may help removal of securement device from the skin." the reporter was contacted for more information regarding the event and the users.Importer reached out to sales department to contact the customer, since this product has been provided as a substitution ¿ ie.They are new users.It is unknown if training was received when the sub was offered.Other similar complaints have been documented for this product family, though the overall complaint rate remains low ((b)(4) over the last 2 years).In most cases, the likely cause has been identified to be related to new users or unfamiliarity of the device, and unintentional use error.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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).H3 other text : device return expected, but not yet received.
Event or Problem Description
Complaint was received via the importer for issues experienced by their customer.End user reported issues with the grip-lok 3601cvc used to secure cvad devices making both the dressing change and the removal challenging and risky to the patients: 1.On doing a dressing change, staff had a hard time separating the cvad from the adhesive strip.The staff are always concerned about the cvad moving into or out of the patient.2.On trying to remove the device when the cvad is ready to be removed, we used alcohol to assist in the removal of the grip-lok device.On a subsequent dressing change on another patient the same day, we tried to change our process to make the procedure safer.We opened the velcro tab first, we used an adhesive remover under the adhesive strip, and then we cleaned and then we attempted to remove the securement device.It was still difficult to remove the cvad from the adhesive.

• Brand Name: GRIP-LOK PICC/CVC SECUREMENT DEVICE, STERILE, MEDIUM
• 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: 18918093
• Report Number: 2182318-2024-00023
• Device Sequence Number: 6892724
• Product Code: KMK
• UDI-Device Identifier: 00618125135011
• UDI-Public: 00618125135011
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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: Health Professional
• Device Model Number: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: 55743248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown