MAUDE Adverse Event Report: TIDI PRODUCTS LLC GRIP-LOK UNIVERSAL SECUREMENT DEVICE, MEDIUM 10PK, STERILE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number 3300M-10PK

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 12/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3: because the complaint originated as an amazon review, information is very limited.Amazon will not provide their customer's contact information.There is no lot information available and the specifics of use of the device (what type or size of tube/device was being secured, was there any skin prep performed, was the device applied per the ifu etc.), are unknown.Without additional information, the complaint cannot be confirmed, nor can root cause be positively determined.Based on historical complaint data, possible root cause is related to new users and device training.As this device is likely being used by end users in a home setting, they may not be following the instructions for use and proper application protocol.An existing capa is open to mitigate these types of complaints and the overall complaint rate for this failure mode/product family is very low (0.006% over the last 2 years).Therefore, no further corrective or preventative actions are necessary.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 Description

A complaint was received via the amazon negative feedback report for sku 3300m-10pk securment devices titled "do not adhere well to skin." the body of the complaint reads: "unless we we received a defective batch of those, they do not adhere to the skin and had to be replace 1 or 2 a day.".

• Brand Name: GRIP-LOK UNIVERSAL SECUREMENT DEVICE, MEDIUM 10PK, 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: 18802303
• MDR Text Key: 336482667
• Report Number: 2182318-2024-00016
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3300M-10PK
• Device Catalogue Number: 3300M-10PK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1