MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDI PRODUCTS, LLC GRIP-LOK; GRIP-LOK SECUREMENT DEVICE FOR SMALL UNIVERSAL CATHETER

Model Number 3200S

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

Product was not returned for evaluation.This report is based on the information provided by the customer.Multiple attempts were made requesting additional complaint information.Without the return of the device nor additional information regarding the event, the root cause could not be determined.The lot number was not provided.Therefore, the device history record for this lot could not be reviewed.Historical complaint data was reviewed and found no other similar complaints for this part.Similar complaints received for other products within this product family are not common and are often from new customers or people using the device for the first time.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary at present.All complaints are trended and reviewed by management on a monthly cadence.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as appropriate.Manufacturer reference file # (b)(4).

Event Description

1 in 4 grip-loks stay on skin for 1 days and many peel off in a few hours.Lack of stickiness/adhesive.No samples or lot information available.

• Brand Name: TIDI PRODUCTS, LLC GRIP-LOK
• Type of Device: GRIP-LOK SECUREMENT DEVICE FOR SMALL UNIVERSAL CATHETER
• 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: 13120414
• MDR Text Key: 290084545
• Report Number: 2182318-2021-00015
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial

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: 3200S
• Device Catalogue Number: 3200S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• 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: Unknown
• Patient Sequence Number: 1