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

Model Number	3300MWA
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
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 the adhesive at the skin and wing level on the device.It was reported that to date, they do not typically use a solution for device removal, though they have sporadically.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 they have visited the hospital to additional instructions for using the device that is expected to help mitigate these problems going forward.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 vygon, tidi's medical device distributor in italy: ¿the device presented criticalities in its affixing and removal: in the latter maneuver, in fact, the fixation was so adherent as to risk compromising the integrity of the skin and accidentally pulling out the catheter".

• Brand Name: 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: 16526631
• Report Number: 2182318-2023-00013
• Device Sequence Number: 2644838
• Product Code: KMK
• UDI-Device Identifier: 00618125134748
• UDI-Public: 00618125134748
• 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: 3300MWA
• Device Catalogue Number: 3300MWA
• 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
• 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