MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; 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)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx2906 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the curled tip of the guidewire got stuck on the catheter tip and when attempting to retract the wire, it made the catheter kink and curl up while still indwelling in the vessel.It is stated the physician had to remove the catheter.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of guidewire becoming stuck within the catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter.Usage residues were observed throughout the sample.The safety button was depressed and the needle was fully withdrawn into the housing.The catheter overlaid the guidewire.The catheter exhibited abundant bends and kinks along its entire length.The tip of the wire appeared caught at the distal end of the catheter.Microscopic inspection of the sample revealed the guidewire to be intact.The coils were misaligned.The coil region appeared caught at the deformed distal end of the catheter.The tip of the catheter was crumpled with inward curving edges.Blood residue was abundant throughout the catheter.The crumpled catheter tip appeared to have contributed to the entanglement of the guidewire coils.Subsequent attempted guidewire retraction appeared to have further buckled the catheter.Such catheter damage can occur if advancement is attempted into tissue and through a tortuous path.A lot history review (lhr) of recx2906 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the curled tip of the guidewire got stuck on the catheter tip and when attempting to retract the wire, it made the catheter kink and curl up while still indwelling in the vessel.It is stated the physician had to remove the catheter.

• Brand Name: ACCUCATH, 18 GX2.25
• 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: 8404570
• Report Number: 3006260740-2019-00515
• Device Sequence Number: 16608970
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC0182250
• Device Lot Number: RECX2906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: Required Intervention