FDA Adverse Event Malfunction Summary report: N

ARTERIAL PRESSURE MONITORING TRAY

MDR report key: 20835988 · Received December 3, 2024

Report

Report Number: 1820334-2024-01584
Event Type: Malfunction
Date Received: December 3, 2024
Date of Event: November 26, 2024
Report Date: August 12, 2025
Manufacturer: COOK INC
Product Code: DQO
UDI-DI: 00827002584136
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

E1 CUSTOMER (PERSON): (B)(6). G4 - PMA/510(K) #: K180846. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE ARTERIAL PRESSURE MONITORING TRAY UNRAVELED. THE PROVIDER PULLED OUT THE WIRE GUIDE TO TEST PRIOR TO PATIENT CONTACT AND FOUND THAT IT WAS UNCOILED AND UNUSABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2292572	ARTERIAL PRESSURE MONITORING TRAY	DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	COOK INC	G58413	15719366	00827002584136

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown