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

Model Number N/A

Device Problem Material Frayed (1262)

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

Event Date 06/14/2021

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 difficult guidewire withdrawal was confirmed.The product returned for evaluation was one 20ga accucath ace peripheral iv catheter assembly.Blood residue was observed throughout the sample.The catheter had been advanced and was not returned.The safety button had been pressed and the needle was partially withdrawn into the housing.The wire protruded from the needle flash notch, which prevented full withdrawal of the needle.The tip of the wire appeared broken proximal of the coil region.The distal fragment was not returned for evaluation.Microscopic inspection of the break revealed a granular fracture surface.Material necking and curved shape memory were observed in the vicinity of the break.The guidewire break features were consistent with material failure due to tensile (pulling) stress.It appeared that attempted withdrawal against resistance resulted in a break in the wire, and subsequent readvancement caused the guidewire to protrude from the needle flash notch.The product ifu states: "if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire." 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 "nurse went to insert the 20ga 2.25" piv and when the wire was deployed there was no trouble advancing, however, when the wire was retracted to reposition the catheter tip inside the vessel, the wire got hung up and the sliding mechanism that retracts the wire was not allowing the wire to be fully retracted.The procedure was stopped and needle was withdrawn from patient.There was no patient harm.The guidewire was checked before insertion." 08/17/2021: the tip of the returned wire appeared broken proximal of the coil region.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (20G)
• 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: 12456183
• MDR Text Key: 271005590
• Report Number: 3006260740-2021-03785
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (y/n): N
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: AC1202252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 08/19/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other