MAUDE Adverse Event Report: CATH F6INF TL JL 4.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Crack (1135); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17818887 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

Prior to opening a pack of 6f 100cm judkins left 4.5 (jl4.5) infiniti catheter, the tech noticed multiple pieces of the blue catheter laying loose in the pack.The product was not used.There was no reported patient injury.The operator is trained to use the device.The device was not opened in a sterile field.The loose blue pieces were found inside the sterile packaging of one, single catheter, where no compromise to the package was noted.The sterile packaging on the other 3 devices had no noted compromise to sterile packaging either.The product was never opened.The devices themselves were intact.The catheters were stored as per the instructions for use (ifu) and hang on pegs on the catheter rack in the locked, secured lab.The devices are taken straight to the lab as soon as they are received.The shipping box was not available.The device will be returned for evaluation together with 3 unused devices with the same lot.

Manufacturer Narrative

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

Complaint conclusion: prior to opening a pack of 6f 100cm judkins left 4.5 (jl4.5) infiniti catheter, the tech noticed multiple pieces of the blue catheter laying loose in the pack.The product was not used.There was no reported patient injury.The operator is trained to use the device.The device was not opened in a sterile field.The loose blue pieces were found inside the sterile packaging of one, single catheter, where no compromise to the package was noted.The sterile packaging on the other 3 devices had no noted compromise to sterile packaging either.The product was never opened.The devices themselves were intact.The catheters were stored as per the instructions for use (ifu) and hang on pegs on the catheter rack in the locked, secured lab.The devices are taken straight to the lab as soon as they are received.The shipping box was not available.The device will be returned for evaluation together with 3 unused devices with the same lot.Three sterile units of infiniti diagnostic catheters ¿cath f6inf tl jl 4.5 100cm¿ were received inside of a clear plastic bag.Additionally, another unit was received for the same complaint in a separate shipment.The devices were unpacked to proceed with the product evaluation.During the visual inspection, all the units were labeled as catalogue number: 534-617t, lot number: 1781887.All the units were in their sealed pouch.No damages or anomalies were observed on the three units that were received first.However, on the other unit, small blue pieces of plastic are observed near the hub and the distal tip of the sealed packed catheter.No other anomalies were observed on the units returned.Per microscopic analysis, a portion of the plastic cover of the body/shaft near the hub is torn or cracked.These pieces are the ones observed dispersed in the sealed pouch and is not a foreign material.The hub is observed yellowish when it should be white.The characteristics of the damage in the plastic and the change of color of the hub could be commonly associated with exposure of the unit to out of specification storage or transportation temperatures.A product history record (phr) review of lot 17818887 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿packaging/pouch/box ¿ foreign material - in sterile package¿ was not confirmed since no foreign material was noted during visual analysis.However, small blue pieces of plastic were noted dispersed in the sealed pouch.The reported event "catheter (body/shaft) - cracked - prior to use" was confirmed since during microscopic analysis, it was noted that the plastic cover of the body near the hub was cracked or torn.This damage caused the dispersed pieces.The characteristics of the damage in the plastic and the change of color of the hub could be commonly associated with exposure of the unit to out of specification storage or transportation temperatures.Nevertheless, the exact cause of the condition could not be defined.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.

• Brand Name: CATH F6INF TL JL 4.5 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11324375
• MDR Text Key: 246840355
• Report Number: 9616099-2021-04265
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014151
• UDI-Public: 10705032014151
• Combination Product (y/n): N
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 534617T
• Device Lot Number: 17818887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2018
• 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