MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported via medwatch report "after an unsuccessful attempt to flush the patient's iv access, the catheter was removed and noted to have a very obvious kink in it.".
Event or Problem Description
It was reported via medwatch report "after an unsuccessful attempt to flush the patient's iv access, the catheter was removed and noted to have a very obvious kink in it.".
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 a kinked 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.The sample was received with an attached extension set.Usage residues were observed within the sample.A sharp kink impression was observed approximately 1.5cm from the distal end.Tactile inspection of the sample revealed the sample to kink preferentially at the site of the kink impression during manual manipulation.Microscopic inspection of the kink site revealed material buckling and discoloration.Inspection of the distal end of the catheter revealed deformation.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, the catheter became occluded during manipulation due to the preferential kinking.The kink impression, discoloration and buckling was consistent with the catheter being subjected to sharp bending/kinking.The usage residues suggested that kinking occurred during attempted device placement, and the tip deformation was consistent with resistance caused by advancement into tissue.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• 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: 9142057
• Report Number: 3006260740-2019-02887
• Device Sequence Number: 1825307
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: AC0182250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 71