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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL SERIVA CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC,
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SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL SERIVA CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, Back to Search Results
Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Patient Problem Abrasion (1689)
Event Date 12/08/2019
Event Type  malfunction  
Manufacturer Narrative
No product sample was received.No testing or visual inspection could be performed, as no product was made available for evaluation.Without the defective unit, we couldn't carry out the failure investigation.The device history record review couldn't be performed because the lot number and the part number are unknown.No root cause could be determined.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
 
Event Description
It was reported that the plastic part kinked outside the skin and always rupture the veins.No patient injury was reported.
 
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Brand Name
JELCO CONVENTIONAL SERIVA CATHETERS
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC,
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15292389
MDR Text Key305263811
Report Number3012307300-2022-16154
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/23/2022
Initial Date FDA Received08/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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