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
Additional Manufacturer Narrative
Device evaluated by mfr: 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 seal failure was determined to be due to products and/or components getting into the seal area during the pouching process.This process was evaluated and found that the root cause of the failure is due to the product not being inserted straight or completely into the machine.Corrective actions are being implemented at the manufacturing site to address this issue and prevent recurrence.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.This complaint has been reported by the customer for one other sku which is run on the same machine and for which the root cause and corrective action will be the same.The operators have been made aware of the complaint to prevent recurrence and corrective action is being implemented at the manufacturing site.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).
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: sealing failure - qty: 19.

• 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: 16208723
• Report Number: 2182318-2022-00153
• Device Sequence Number: 4340757
• 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): Unknown
• 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