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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
Catalog Number AC0202250
Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex1409 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported er rn was coaching another er rn to place on the 7th fl when accucath was attempted in the forearm of patient.Rn was unable to remove the guidewire once catheter resistance was felt.Surgeon was called and said to remove catheter and order ultrasound to ensure no foreign bodies left in patient.Insertion site was marked.No patient harm was done.
 
Event Description
It was reported er rn was coaching another er rn to place on the 7th fl when accucath was attempted in the forearm of patient.Rn was unable to remove the guidewire once catheter resistance was felt.Surgeon was called and said to remove catheter and order ultrasound to ensure no foreign bodies left in patient.Insertion site was marked.No patient harm was done.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.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 accucath placement complications was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced.The safety button was depressed and the needle was fully withdrawn in to the housing.The catheter exhibited extensive buckling and kinking along its entire length.The guidewire was broken proximal of the coil.The distal wire fragment was not returned.Microscopic inspection of the catheter confirmed extensive deformation.The tip of the catheter was buckled inward.Microscopic inspection of the guidewire break revealed a granular fracture surface.Necking was observed in the vicinity of the break.The catheter tip deformation was consistent with attempted advancement against resistance, such as into tissue.The catheter shaft deformation was consistent with compression caused by guidewire retraction against the deformed catheter tip.The break in the guidewire was consistent with tensile failure caused by pulling.Combined, it appeared that initial placement was attempted into tissue, causing catheter tip damage and subsequent removal attempts compressed the catheter and broke the guidewire.H3 other text : evaluation findings are in section h.11.
 
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Brand Name
ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of Device
CATHETER,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
MDR Report Key11386662
MDR Text Key238854309
Report Number3006260740-2021-00520
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 04/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAC0202250
Device Lot NumberREEX1409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Date Manufacturer Received04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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