MAUDE Adverse Event Report: TIDI PRODUCTS LLC PLAN 1 HEALTH PICC/CVC SECUREMENT DEVICE WHITE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	01.60.70.10
Medical Device Problem Codes	Material Separation (1562); Separation Problem (4043)
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 solely on information provided by the reporter.There was no patient or caregiver injury reported.The reporter was contacted to provide additional information regarding the alleged defect or failure.To date, no additional information has been provided.Historical complaint data review identified no other similar complaints reported for this sku in the last 5 years.Previous complaints for this failure mode in similar products were identified, however the complaint rate remains very low.These issues were determined to most likely be related to pressure settings issues on the machine.Review of the manufacturing records for lot: 52419486 identified no pressure-related issues noted.At this time, there is not enough information available to confirm the complaint.Likewise, the root cause cannot be positively determined.Therefore, no corrective or preventive actions are required currently.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).
Event or Problem Description
It was reported by plan 1 health, a european importer, that they had received a complaint from their distributor and provided an image with no further details of the complaint issue.It appears to show delamination of the adhesive and the adhesive layer stuck to the catheter hub.

• Brand Name: PLAN 1 HEALTH PICC/CVC SECUREMENT DEVICE WHITE
• 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: 16545814
• Report Number: 2182318-2023-00017
• Device Sequence Number: 17723543
• Product Code: KMK
• UDI-Device Identifier: 00618125143863
• UDI-Public: 00618125143863
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/28/2023

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: 01.60.70.10
• Device Catalogue Number: 01.60.70.10
• Device Lot Number: 52419486
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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