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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL JELCO SAFETY VIAVALVE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
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NULL JELCO SAFETY VIAVALVE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Lot Number 3790841
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Event Description
It was reported that there was difficulty with insertion of the device into the patients.No patient injury was reported.
 
Manufacturer Narrative
No information has been provided to date a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
JELCO SAFETY VIAVALVE
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
Manufacturer (Section G)
NULL
MDR Report Key15401985
MDR Text Key306074170
Report Number3012307300-2022-18678
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Lot Number3790841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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