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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number AC0202250
Device Problems Difficult to Remove (1528); Retraction Problem (1536); Physical Resistance (2578); Material Twisted/Bent (2981)
Patient Problem Blood Loss (2597)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents. Based on a review of this information, the following was concluded: the reported complications were confirmed, but the exact cause could not be determined. A photo of two images was provided for investigation. Both images show different angles of the accucath safety chamber and accucath catheter. The catheter was not attached to the needle. The full length of the chamber and catheter was not visible in either image. The safety activation button appeared to be recessed within the handle, but what appeared to be the needle shaft was extending from the safety chamber. The distal tip of the needle and guidewire were not visible in the image. The guidewire slider appears to be positioned in the middle of the track. Only the distal segment of the catheter was visible in each image. A red colored material, which appeared to be blood residue, was visible within the catheter. Two kinks were observed in the visible section of catheter shaft. The guidewire was not visible within the catheter. At this time, based on the limited evidence provided with the returned photo, it is unknown what caused the reported event. It is unknown if any complications associated with the clinical setting affected the functional performance of the returned device. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
On 10/26/2016 ¿ per sales representative, facility reported that a nurse inserted a guide wire, slid the catheter into place, and had perfect placement. Nurse then pressed the activator to remove the needle. The nurse stated she felt a click that felt more like something inside the iv housing breaking than the usual release that's supposed to take place. The button remained depressed but the needle did not retract. The nurse then slowly, manually attempted to remove the needle and guidewire. They did not slide out as easily as expected. The nurse had to apply increasing pressure pulling away. Eventually they retracted but with a notable amount of friction, and resistance. The nurse noticed that there was seemingly more blood on the guide wire tip then she usually notices after extracting it. The nurse attempted to aspirate and flush the iv with some hesitation because of the amount of resistance she had trying to pull out the needle and guide wire. The iv was not able to work so the nurse pulled it out of the patient. When examining the catheter she noticed that it had a very twisted and contorted look as if it had a decent amount of pressure applied from the catheter tip toward the hub. Enough to make obvious bends in the catheter. No patient injury reported.
 
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Brand Name20GA, ACCUCATH IV CATHETER, 2.25", BASIC
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
maren treft
605 n. 5600 w.
salt lake city, UT 84116
8015225964
MDR Report Key6107076
MDR Text Key60556627
Report Number3006260740-2016-00604
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110948
UDI-Public(01)00801741110948
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAC0202250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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