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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,LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number AC0202250
Device Problems Failure to Advance (2524); Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2020
Event Type  malfunction  
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 damaged accucath was confirmed. The product returned for evaluation was one accucath peripheral iv assembly. Usage residues were observed throughout the sample. The catheter had been advanced and was not returned for evaluation. The safety was activated and the needle was partially withdrawn into the housing. The guidewire protruded from the needle flash notch. The wire was bent near the needle carrier. Deformation was observed within the coil region. Microscopic inspection of the wire confirmed deformation of the coil region. The guidewire was fractured in the coil region and the distal fragment was not returned for evaluation. The fracture surface was partially granular. A region of increased luster as observed. Curved shape memory was observed in the vicinity of the break. The coil deformation and bending next to the carrier were consistent with attempted insertion against resistance, such as into tissue. The coil fracture was consistent with damage initiated by retraction against the needle bevel following that insertion attempt. A lot history review (lhr) of rees1528 showed no other similar product complaint(s) from this lot number.
 
Event Description
Was reported accucath guidewire protruding from needle. Needle did not retract and guidewire popped through the needle. Missing metal piece from needle. Additional information received: the nurse was unable to thread the catheter guidewire, despite the ultrasound confirmation that the needle tip was in the vein. The iv angiocath advanced without difficulty, but the full length of the catheter would not advance. Approximately 50% of the catheter remained external; so it was discontinued. After assessing the needle, the nurse noticed the guidewire was protruding from the side of the needle, opposed to the end of the needle, which is typical. Medwatch (b)(4) received (b)(6) 2020: the nurse was unable to thread the catheter guidewire, despite the ultrasound confirmation that the needle tip was in the vein. The iv angiocath advanced without difficulty, but the full length of the catheter would not advance. Approximately 50% of the catheter remained external; so it was discontinued. After assessing the needle, the nurse noticed the guidewire was protruding from the side of the needle, opposed to the end of the needle. On (b)(6) 2021. The returned wire was fractured, the distal fragment was missing and not returned.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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 Key11313967
MDR Text Key249721989
Report Number3006260740-2021-00322
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 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREES1528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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: 02/11/2021 Patient Sequence Number: 1
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