MAUDE Adverse Event Report: TIDI PRODUCTS LLC 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned for evaluation.Therefore, this report is based on the information provided by the customer.There was no patient or caregiver injury and no medical intervention was required as a result of this event.Historical complaint data review identified three other similar complaints for this sku in the last year, one of which that was reported for the same lot as the one associated with this report.The complaints, for delamination of the adhesive resulting in excessive stickiness were confirmed at that time.However, testing of sample retains, returned samples from the customer, and on-hand product could not reproduce the problem.The root cause was believed to be an intermittent process setting-related issue that was identified and corrected during production, but not noted in the manufacturing documentation.Due to an observed increase in reportable complaints for securement devices, a capa has been launched to investigate.Therefore, no further corrective or preventative actions are necessary.We will continue to monitor for these types of complaints going forward.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 vygon, tidi's medical device distributor in italy, that: "these devices are not easy to use, as the glue that is supposed to stabilise the cvc to the device is very strong and it is difficult to remove it and also causes adhesion with sterile gloves.The event does not seem to be related to a potential product nonconformity, it seems to be the usual usability issue." report is being submitted because excessive adhesive, resulting in the lines getting stuck in/to the device may result in unintended removal of the medical lines.These events may interrupt patient treatment and may contribute to patient injury.At this time, there is no reported injury.

• Brand Name: TIDI PRODUCTS, LLC 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: 14915885
• Report Number: 2182318-2022-00077
• Device Sequence Number: 1932638
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 49180015
• 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: 06/09/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown