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

Model Number 3300MWA

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported by a distributor that that end user is finding product does not stay adhered to patients skin.

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
• Type of Device: 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
• MDR Text Key: 334800285
• Report Number: 2182318-2024-00008
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1