MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G58402
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Staff in the surgical icu went to grab a pediatric arterial pressure monitoring set for one of their patients.It was found that the package was sealed from the manufacturer, but the set was not in the package.There is nothing in the set except for a syringe.Other packages of these a-line sets were also found to be empty.In all, there were 4 different lot numbers found to be affected.Currently, the hospital has no additional pediatric a-line kits on hand, since the ones in reserve were also found to be empty.Lots affected: 15898496 x1, 15066560 x1, 15948531 x1, 15188336 x5.
Event or Problem Description
Staff in the surgical icu went to grab a pediatric arterial pressure monitoring set for one of their patients.It was found that the package was sealed from the manufacturer, but the set was not in the package.There is nothing in the set except for a syringe.Other packages of these a-line sets were also found to be empty.In all, there were 4 different lot numbers found to be affected.Currently, the hospital has no additional pediatric a-line kits on hand, since the ones in reserve were also found to be empty.Lots affected: 15898496 x, 15066560 x1, 15948531 x1, 15188336 x5.

• Brand Name: COOK
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 21376257
• Report Number: 21376257
• Device Sequence Number: 3826536
• Product Code: DQO
• UDI-Device Identifier: 00827002584020
• UDI-Public: (01)00827002584020(17)260124(10)1518836
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025
• Report Date (Section F): 02/11/2025

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: G58402
• Device Catalogue Number: APM-2.5-15-1-2.5
• Device Lot Number: 15188336,15948531,15066560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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
• Date Report Sent to FDA: 02/11/2025