MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL PIVC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 4033-AI

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

It was reported that a minor patient was not able to be canalized stating that the device caused difficulties to puncture.Immediately, when trying to canalize patient it was noticed that the device was not sharp which made the canalization difficult and painful for the patient.The customer reported that the device did not have the tab for support when handling and that it is hard to see the venous return.No further information is known.

Manufacturer Narrative

No product was returned for investigation.The photographs provided were not useful for investigation purposes as potential product defects are not visible.Therefore, no failure investigation could be done.A device history record review showed no anomalies during the manufacturing process of the lot involved.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.No product information has been provided to date.

• Brand Name: JELCO CONVENTIONAL PIVC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 15547235
• MDR Text Key: 306510294
• Report Number: 3012307300-2022-21541
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4033-AI
• Device Lot Number: 4249664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1