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

Model Number 5804.17

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Skin Tears (2516)

Event Type  Injury  

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 provided and there appear to be no anomalies or nonconformances which could have contributed to this event noted in the device history record for this lot.Historical complaint data was reviewed and found no other similar complaints for this part.No other complaints were received in relation to this lot number.The instructions for use were reviewed and appear to be adequate for the use of this product.Therefore, no additional 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

According to the customer there was a bleeding from the piccline.The piccline was on the floor and the patient was bleeding.(piccline applied the same day with this new device).Intense bleeding with need to put a pressure bandage to stop the bleeding.Updated complaint description received 11/15/2021: the bleeding bandage was still in place but the picc line underneath was no longer held and that is how he ended up on the ground.

• Brand Name: TIDI PRODUCTS, LLC GRIP-LOK
• Type of Device: PICC / CVC SECUREMENT DEVICE WITH ADHESIVE,,
• 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: 12930904
• MDR Text Key: 282291725
• Report Number: 2182318-2021-00012
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5804.17
• Device Catalogue Number: 5804.17
• Device Lot Number: 41172328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 12/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR