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

Model Number	3300MW-TA-3
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: 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 reporter was contacted for more information regarding the event and the users, and it was reported that they are having difficulty with removal of the device due to the device reportedly being too sticky.It was reported that to date, they do not use a solution for device removal.The instructions for use (ifu) contain the note: "use of an alcohol swab may help removal of securement device from the skin." a copy of the current ifu was provided and it was reported by the contact (importer) that a sales representative has visited the hospital to provide training.The lot numbers associated with this complaint are unknown.Other similar complaints have been documented for similar devices.In most cases, the likely cause has been related to new users and unintentional use error.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).
Event or Problem Description
It was reported by teleflex on 2023-03-21: "when applying the device during replacement, the device gets torn.It is then unusable and procedure cannot be finished with this product." when contacted for additional information about the alleged defect, the customer replied on (b)(6) 2023: "issues related to the removal of the device was reported, during the removal the attachment system had difficulty in removing, which almost led to the removal of the picc." based on new information provided, this complaint was determined to be reportable with the following rationale noted: difficulty removing the device may result in unintended removal of the medical lines.These events may interrupt patient treatment and may contribute to patient injury.Therefore, this is reportable.There have been no injuries reported that are associated with this complaint.

• Brand Name: TELEFLEX GRIP-LOK PICC/CVC SECUREMENT DEVICE WITH ADHESIVE
• 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: 16799344
• Report Number: 2182318-2023-00031
• Device Sequence Number: 20427480
• Product Code: KMK
• UDI-Device Identifier: 00618125135455
• UDI-Public: 00618125135455
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 03/21/2023

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: 3300MW-TA-3
• Device Catalogue Number: 3300MW-TA-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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