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

Catalog Number 4030-AI

Device Problems Break (1069); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

One smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter was returned for analysis.Visual inspection did not confirm the reported issue, the needle was noted to be sharp, and the bevel did not show any defect.It was also noted that the needle is assembled with the hub by the press fit technology without the use of any resin.It is possible that is possible that for a temporary misalignment of one of the assembly station the needle clashed on the plastic hub and was occluded by some small plastic burr.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.

Event Description

Information was received indicating that while in use of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, it was noted that some blood had come back, the vein had broken down when the user wanted to move the catheter back into the vein.It was also reported that by removing the catheter, the user realized that the catheter needle had pierced the white plastic catheter.No further adverse effects were reported.

• Brand Name: JELCO
• 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
• MDR Report Key: 12470712
• MDR Text Key: 271374551
• Report Number: 3012307300-2021-09357
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 4030-AI
• Device Lot Number: 3468118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1