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

Model Number	3601CVC
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint#: (b)(4) this product does not hold the picc line secure in place the line was still able to move.Risk of picc line traveling.Recurring issue.
Additional Manufacturer Narrative
H3: product is scheduled to be returned but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.Complaint was reported to the manufacturer by mcarthur medical, a canadian importer for grip-lok devices.Additional information related to the incident was requested, along with return samples for evaluation.The importer reached out to their customer service department to contact the customer, since this product has been provided as a sub ¿ ie.They are new users.Unknown if training was received when the sub was offered.As of march 7, 2024, no new information has been received, nor has the return samples been provided.At this time, there is no evidence that a manufacturing error contributed to the reported failure.Based on historical complaint data and information currently available, likely root cause is due to new users and device training issues.Based on similar complaints for this failure mode and sales for this product family, this issue has a complaint rate of 0.012% during that time.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 CVC SECUREMENT DEVICE STERILE, MEDIUM
• 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: 18870783
• Report Number: 2182318-2024-00018
• Device Sequence Number: 14195777
• Product Code: KMK
• UDI-Device Identifier: 00618125135011
• UDI-Public: 00618125135011
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: UNKNOWN
• 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: 02/09/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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