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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0202250
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
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 complaint of a broken accucath guidewire was confirmed; however, the root cause was not identified. The product returned for evaluation was one radiographic image which appeared to depict an accucath guidewire. The guidewire appeared to be broken off within the arm of a patient. The guidewire appeared to be curved. The coil region was visible. The guidewire segment appeared to be several centimeters in length. What appeared to be a broken accucath guidewire was evident in the submitted radiograph; however, inspection of the image was insufficient to identify the cause. Such damage can occur if the wire is retracted against the introducer needle at an angle. The curve in the wire suggested that some insertion resistance may have been encountered, which can contribute to wire damage during retraction. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported "this morning one of my customers informed me that they had a 20g 2. 25 inch accucath that they placed in the ed where the wire broke off in the patients skin. This happened on the 26th at roughly 9pm. I have attached an image of the x-ray they sent me. Unfortunately this caused a sentinel event for the hospital. The wire was successfully retrieved from the patient that same evening. They retrieved 4. 5cm of the accucath wire from the patients top layer of their skin. Based off the image it does not look like the wire ever reached a vein. " "was there any patient harm reported? yes".
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11380311
MDR Text Key233719349
Report Number3006260740-2021-00492
Device Sequence Number1
Product Code FOZ
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 company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
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

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1
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