MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF JL 3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 538418

Device Problems Crack (1135); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

As reported, a 4f judkins left 3.5 infiniti catheter had the absence of threads on the head of the probe making it impossible to connect equipment.The issue was noted during prep.The procedure was completed with another unknown device.There was no reported patient injury.The product was stored, handled, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no kinks or other damages noted prior to inserting the product into the patient.Additional procedural details were requested but are unknown.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18110881 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, a 4f judkins left 3.5 infiniti catheter had the absence of threads on the head of the probe making it impossible to connect equipment.The issue was noted during prep.The procedure was completed with another unknown device.There was no reported patient injury.The product was stored, handled, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no kinks or other damages noted prior to inserting the product into the patient.One non-sterile cath f4 inf jl 3.5 100cm unit was received for analysis inside a plastic bag.During visual inspection, the hub was found cracked on the luer hub section.Sem analysis was performed on the cracked area of the hub and presented evidence of fatigue striations and plastic deformations.A product history record (phr) review of lot 18110881 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The events reported by the customer as "luer hub - catheters - cracked - during prep¿ and "luer hub - catheters - incompatibility/fit - during prep¿ were confirmed since the hub of the unit was received cracked, thus the component cannot fit as intended.The fatigue striations and plastic deformations found on the hub is 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.The exact source of the high tensile force cannot be identified with the information available.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.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), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported, a 4f judkins left 3.5 infiniti catheter had the absence of threads on the head of the probe making it impossible to connect equipment.The issue was noted during prep.The procedure was completed with another unknown device.There was no reported patient injury.The product was stored, handled, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no kinks or other damages noted prior to inserting the product into the patient.Additional procedural details were requested but are unknown.The device will be returned for evaluation.Addendum: during visual inspection of the returned device, the hub was found cracked on the luer hub section.

• Brand Name: CATH F4 INF JL 3.5 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): 14201 NW 60 AVENUE; miami lakes FL 32574
• Manufacturer Contact: karla castro ; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15479346
• MDR Text Key: 301014784
• Report Number: 9616099-2022-06013
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 538418
• Device Catalogue Number: 538418
• Device Lot Number: 18110881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANOTHER UNKNOWN DEVICE.