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

Catalog Number	AC0202250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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were observed throughout the sample.The catheter was advanced.The safety button was depressed and the needle was fully withdrawn in to the housing.The catheter exhibited extensive buckling and kinking along its entire length.The guidewire was broken proximal of the coil.The distal wire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.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Common Device Name: 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 Key: 11386662
• Report Number: 3006260740-2021-00520
• Device Sequence Number: 11489840
• Product Code: FOZ
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AC0202250
• Device Lot Number: REEX1409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other