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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. JELCO® I.V. CATHETERS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL, ASD, INC. JELCO® I.V. CATHETERS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 4013-AI
Device Problems Bent (1059); Difficult or Delayed Positioning (1157)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the cannulas of a jelco® i. V. Catheter bend/snap right after implementation. There was no patient injury related to the event.
 
Manufacturer Narrative
Additional information was received indicating that a smiths medical jelco® i. V. Catheter bent twice directly when advancing the catheter. It was reported that the material is noted to be thinner and more rigid than normal. The patient was reported to be fine.
 
Manufacturer Narrative
85 unused units were returned for evaluation. Of the 85, 20 were visually insepected. Four units were found to have a bevel not correctly molded, and catheter contour that exceeded the lower specification limit. The reported customer complaint has been confirmed. The root cause has been determined to be related to an assembly line issue.
 
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Brand NameJELCO® I.V. CATHETERS
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7556961
MDR Text Key109746132
Report Number3012307300-2018-01994
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 user facility
Type of Report Initial,Followup,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2022
Device Catalogue Number4013-AI
Device Lot Number3449020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

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