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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
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.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12470712
MDR Text Key271374551
Report Number3012307300-2021-09357
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4030-AI
Device Lot Number3468118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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