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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAIN; CATHETER, IRRIGATION
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BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAIN; CATHETER, IRRIGATION Back to Search Results
Catalog Number UNK NAVARRE UNIVERSAL DRAIN
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 05/30/2006
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported in an article in american journal of roentgenology titled 'percutaneous drainage of abdominal abscesses in pediatric crohn's disease', that drainage catheters dislodged in three cases which required manipulation.One catheter dislodged due to the hub's break and was replaced, one catheter was mobilized for better drainage of a residual superficial collection, and a 6-french catheter was exchanged for an 8-french catheter for drainage of thick material.There current status of the patients is unknown.
 
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Reference: rypens, f., dubois, j., garel, l., deslandres, c., & saint-vil, d.(2007).Percutaneous drainage of abdominal abscesses in pediatric crohn's disease.American journal or roentgenology, 118, 579-585.Doi:10.2214/ajr.06.0181.
 
Event Description
It was reported in an article in american journal of roentgenology titled 'percutaneous drainage of abdominal abscesses in pediatric crohn's disease', that drainage catheters dislodged in three cases which required manipulation.One catheter dislodged due to the hub's break and was replaced, one catheter was mobilized for better drainage of a residual superficial collection, and a 6-french catheter was exchanged for an 8-french catheter for drainage of thick material.There current status of the patients is unknown.
 
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Brand Name
NAVARRE UNIVERSAL DRAIN
Type of Device
CATHETER, IRRIGATION
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10182830
MDR Text Key196056777
Report Number3006260740-2020-02183
Device Sequence Number1
Product Code GBX
Combination Product (y/n)N
PMA/PMN Number
K951475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK NAVARRE UNIVERSAL DRAIN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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