MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5.2ST+ JL 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533553

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for testing and evaluation.   concomitant medical product: harnbank from braun.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the physician cannot connect the braun harnback infusion therapy set to the two 5.2f 4 100 cm super torque plus straight judkins left 4 catheters.The luer lock connection is not working properly and was too thin.For this reason, the braun cock cannot be connected.There was no reported patient injury.The products were only unpacked and not used on the patient, as the problem had already been identified before the examination.The product was treated professionally by the customer.The device was stored and handled per the ifu.There was no damage to the super torque diagnostic catheter noticed prior to opening the package.Other additional procedural details were requested but were unknown.

Manufacturer Narrative

Complaint conclusion: as reported, the physician cannot connect the braun harnback infusion therapy set to the two 5.2f 4 100 cm super torque plus straight judkins left (b)(4) catheters.The luer lock connection is not working properly and was too thin.For this reason, the braun cock cannot be connected.There was no reported patient injury.The products were only unpacked and not used on the patient, as the problem had already been identified before the examination.The product was treated professionally by the customer.The device was stored and handled per the ifu.There was no damage to the super torque diagnostic catheter noticed prior to opening the package.Additional procedural details were requested but were unknown.Two non-sterile supertorque plus diagnostic catheters (cath f5.2st+ jl 4 100cm) were received for analysis.No damages or anomalies were observed on the returned units.The catheters were identified with number one and two in order to perform a separate evaluation.The unit identified as number one is evaluated under 2019-00097164-1 and the unit identified as number two is evaluated under 2019-00097164-2.Functional analysis was performed with the purpose to determine if incompatibility/fit is experienced.The returned catheter was attached via the luer hub to a lab sample injector tubing, observing a correct fitting during the connection process.Dimensional analysis was performed to verify the correct outer diameter (od) of the luer hub thread.Dimensional analysis results were found within specification.A product history record (phr) review of lot 17871746 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The product malfunctions reported by the customer as ¿luer hub incompatibility/fit with injector tubing/iv tubing¿ were not confirmed.The functional test was performed successfully with a lab sample injector tubing and the dimensional analyses were found within specification.The reported infusion set experiencing the connection difficulty was not returned for analysis.The exact cause of reported events could not be conclusively determined during the product analyses.Handling factors might have contributed to this issue.According to the instructions for use (ifu), which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ neither the phr review nor the product analyses suggest 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.

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2019-03386 complaint conclusion: as reported, the physician cannot connect the braun harnback infusion therapy set to the (b)(4) 5.2f 4 100 cm super torque plus straight judkins left (b)(4) catheters.The luer lock connection is not working properly and was too thin.For this reason, the braun cock cannot be connected.There was no reported patient injury.The products were only unpacked and not used on the patient, as the problem had already been identified before the examination.The product was treated professionally by the customer.The device was stored and handled per the ifu.There was no damage to the super torque diagnostic catheter noticed prior to opening the package.Additional procedural details were requested but were unknown.(b)(4) non-sterile supertorque plus diagnostic catheters (cath f5.2st+ jl 4 100cm) were received for analysis.No damages or anomalies were observed on the returned units.The catheters were identified with number (b)(4) and (b)(4) in order to perform a separate evaluation.The unit identified as number (b)(4) is evaluated under 2019-00097164-1 and the unit identified as number (b)(4) is evaluated under 2019-00097164-2.Functional analysis was performed with the purpose to determine if incompatibility/fit is experienced.The returned catheter was attached via the luer hub to a lab sample syringe, observing no anomalies during the connection process.Dimensional analysis was performed to verify the correct outer diameter (od) of the luer hub thread.Dimensional analysis results were found within specification.The product malfunctions reported by the customer as ¿luer hub incompatibility/fit with injector tubing/iv tubing¿ were not confirmed.The reported infusion set experiencing the connection difficulty was not returned for analysis.The functional test was performed successfully with a lab sample syringe and the dimensional analyses were found within specification.The exact cause of reported events could not be conclusively determined during the product analyses.Handling factors might have contributed to this issue.According to the instructions for use (ifu), which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ neither the phr review nor the product analyses suggest 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.

• Brand Name: CATH F5.2ST+ JL 4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9429516
• MDR Text Key: 199105312
• Report Number: 9616099-2019-03387
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032012680
• UDI-Public: 20705032012680
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 533553
• Device Catalogue Number: 533553
• Device Lot Number: 17871746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1