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

Model Number	3300MWA
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a distributor that that end user is finding product does not stay adhered to patients skin.
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.There was no lot information or product samples available.Without lot information, the device history record could not be reviewed, nor could retain samples be pulled for testing.This failure mode has a low complaint rate, however similar complaints have been received and are typically reported by new users and many are found to be related to a failure to follow the product instructions for use (ifu).The reporter was contacted for more information regarding the event and the users.It was reported that the end users are new to using this device and they are having difficulty with the grip-lok remaining adhered to the skin after application.Additional information provided was that many of the complaint units are being saturated with oral secretions.The ifu contains the note: ¿replace securement device if soiled or saturated in fluid or if device shows signs of wear or damage.¿ a copy of the current ifu was provided.At this time, it appears that the root cause is related to new users and a failure to follow instructions for use.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 PICC/CVC SECUREMENT DEVICE, STERILE
• 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: 18647503
• Report Number: 2182318-2024-00008
• Device Sequence Number: 8264092
• Product Code: KMK
• UDI-Device Identifier: 00618125134748
• UDI-Public: 00618125134748
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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
• Device Model Number: 3300MWA
• Device Catalogue Number: 3300MWA
• Device Lot Number: UKNOWN
• 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: 01/09/2024
• Initial Report FDA Received Date: 02/05/2024
• 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