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

Model Number	3601CVC
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Compliant was reported by a distributor in japan for a nonconformance identified during incoming inspection at their facility in japan.Details of nonconformity: not sealed - qty: 1.
Additional Manufacturer Narrative
The complaint product was not available for evaluation.Therefore, this report is based on customer-provided information only.Multiple images of the defect were provided by the customer and evaluated.The root cause of the seal failure was determined to be due to a failure to identify and discard the affected product during pouching process.At machine startup, if the dies have not reached the appropriate temperature, this defect could occur.Operators are trained to identify and discard the affected product.Production documentation was reviewed and identified no nonconformances noted and all reviewed samples passed inspection.Historical complaint data review identified no other complaints for this failure mode for this sku in the past 5 years.The operators have been notified of the complaint for awareness and to prevent recurrence.No further corrective or preventive actions are required at this 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 refence file (b)(4).

• Brand Name: GRIP-LOK UNIVERSAL CVC SECUREMENT DEVICE
• 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: 16208907
• Report Number: 2182318-2022-00154
• Device Sequence Number: 14566373
• Product Code: KMK
• UDI-Device Identifier: 00618125135011
• UDI-Public: 00618125135011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/20/2022

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: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: 53713809
• 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: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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