MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recz2892 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the placer checked the accucath wire prior to deployment by pushing it out and fully retracting it back in the needle tip.It was stated that the placer stuck the patient, deployed the guidewire and catheter with no issues or resistance noted.While attempting to safety the device, the accucath would not fully safety.The entire device and catheter were removed together.No patient injury.
Event or Problem Description
It was reported that the placer checked the accucath wire prior to deployment by pushing it out and fully retracting it back in the needle tip.It was stated that the placer stuck the patient, deployed the guidewire and catheter with no issues or resistance noted.While attempting to safety the device, the accucath would not fully safety.The entire device and catheter were removed together.No patient injury.
Additional 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 resistance during the device insertion procedure was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 1.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The sample was received with the safety mechanism depressed.The needle was fully withdrawn into the housing.The catheter overlaid the guidewire.Several kinks were observed along the length of the catheter.Microscopic inspection of the catheter confirmed several kinks along its length.The catheter tip exhibited deformation.Following removal of the catheter, inspection of the guidewire revealed misalignment of the coils.Microscopic inspection of the wire revealed a kink in the coiled region, resulting in coil misalignment.The wire was intact.The guidewire and catheter deformation were consistent with attempted insertion against resistance, such as into tissue or at a too-steep insertion angle.It appeared that the wire was deformed and became caught within the catheter during attempted retraction.Such interference can prevent proper retraction of the needle upon depression of the safety button.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8951897
• Report Number: 3006260740-2019-02566
• Device Sequence Number: 10844909
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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 Model Number: N/A
• Device Catalogue Number: AC0201250
• Device Lot Number: RECZ2892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1