MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV CATHETERS; PERIPHERAL INTRAVENOUS CATHETERS

Catalog Number 4030-AI

Device Problems Break (1069); Material Separation (1562)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461); Insufficient Information (4580)

Event Type  Death  

Event Description

It was reported that the patient was cannulated in the left upper limb, remaining permeable, the patient had a blue code.After 30 minutes of cannulation occurred an extravasation, the catheter was withdrawn and it came out incomplete, apparently it suffered a fracture in the blood vessel.A control x-ray was ordered, but it could not be taken due to the critical condition of the patient, who presented code blue again and died.The device is not available to be sent to the provider.The treating physician requested an x-ray to determine the position of the catheter without finding it.There is insufficient information to determine any details regarding patient additional clinical signs (blue code is cardiac or respiratory arrest - there is insufficient information to determine with certainty).

Manufacturer Narrative

Device evaluation: no product was returned for investigation.No photographs have been provided, therefore no failure investigation could be performed.The complaints database shows no other complaints recorded on the lot number.Review of the complaints database was extended to the product code, showing no justified complaints were logged alleging the same defect in the last three years.Five additional complaints related to broken or detached catheter tube were found; the assessment for all of them was indeterminate as no product nor photographs were returned for the investigation, therefore there was no evidence available to be able to confirm the alleged defect.Customer does not report any issue on the product prior or during venipuncture.The issue was detected 30 minutes after the product insertion.This indicates that the product didn?t show visible defects (as tube tears or damages) prior use.Assuming that the device didn?t appear to be defective prior use (otherwise venipuncture would have not been performed), damages to the catheter tube may occur for an improper use of the device, like a needle reinsertion (the instruction for use clearly warns the user: ?do not reinsert the needle into the catheter at any time").Despite the defective sample was not available, a review of the manufacturing process has been performed.Review of the manufacturing records of the machines/lines involved showed no anomalies related to the referenced defect were detected during the manufacturing of the complained lot.No maintenance tickets were logged in the periods of interest for issues related to the referenced defect.On the basis of the available evidence, we cannot confirm whether a quality related issue has resulted in the customer reported problem.The reported issue could not be confirmed, therefore no further action will be implemented at this time.The dhr review shows no anomaly was recorded during the manufacturing of the lot involved.The cause of the reported problem could not be determined.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: JELCO CONVENTIONAL JELCO IV CATHETERS
• Type of Device: PERIPHERAL INTRAVENOUS CATHETERS
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15744885
• MDR Text Key: 303172332
• Report Number: 3012307300-2022-26830
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4030-AI
• Device Lot Number: 4254958
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death