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

Model Number N/A

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.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 on may 7th by iv therapy member in ed who placed accucath right above ac 3cm with ultrasound assistance.Got flash, advanced wire, tried to advance cath but hit resistance, attempted to pull wire back but wire was stuck.Catheter was able to be pulled back successfully and removed by ir doctor.When it was removed the coiled tip didn't coil back the way it should have.

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 a damaged accucath guidewire was confirmed.The product returned for evaluation was one accucath peripheral iv catheter assembly.The safety button was depressed and the needle was fully withdrawn into the housing.The catheter was not returned.The guidewire coils appeared to be misaligned.Microscopic inspection of the guidewire confirmed a kink within the coil region, resulting in the misaligned coils.The wire was intact.Biological residue was observed on the wire.The wire deformation was consistent with advancement against resistance, such as into tissue.The biological residue suggested that resistance occurred during device placement.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported on may 7th by iv therapy member in ed who placed accucath right above ac 3cm with ultrasound assistance.Got flash, advanced wire, tried to advance cath but hit resistance, attempted to pull wire back but wire was stuck.Catheter was able to be pulled back successfully and removed by er doctor.When it was removed the coiled tip didn't coil back the way it should have.

• 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 Key: 11893589
• MDR Text Key: 252939213
• Report Number: 3006260740-2021-02067
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 113