MAUDE Adverse Event Report: CATH F5.2+ JR4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	533552
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the luer hub of a5.2f 100cm judkins right (jr4) supertorque plus angiographic catheter was cracked and separated.Multiple attempts to obtain additional information were made with no response.There was no reported patient injury.One nonsterile cath f5.2+ jr4 100cm device was received for analysis inside a plastic bag.Visual analysis revealed a cracked and separated luer hub.Sem results of the affected area presented evidence of plastic deformation and fatigue striations.No other anomalies were observed during the product evaluation.The phr review for lot 17992387 does not suggest that the failure experienced by the customer could be related to the manufacturing process.The complaint reported by the customer as ¿luer hub ¿ catheters-separated¿ and ¿luer hub ¿ catheters-cracked¿ were confirmed because the hub was found to be cracked and separated.Plastic deformation and fatigue striations are commonly associated with separations caused by material tensile overload therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the separation.Procedural/handling factors such as unsuitable storage conditions (incorrect temperature, lighting, humidity), rough handling, incorrect choice of ancillary devices and/or improper technique (excessive force) may have contributed to this issue.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54°c (130) may damage the catheter.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, the probe at the base of the 5.2f 100cm judkins right (jr4) supertorque plus angiographic catheter was broken.Per visual analysis the hub was found to be cracked and separated.There was no reported patient injury.The device will not be returned for analysis.

• Brand Name: CATH F5.2+ JR4 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12326756
• Report Number: 9616099-2021-04782
• Device Sequence Number: 4115501
• Product Code: DQO
• UDI-Device Identifier: 10705032012676
• UDI-Public: 10705032012676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 533552
• Device Catalogue Number: 533552
• Device Lot Number: 17992387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: Initial
• Patient Sequence Number: 1