MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20GX2.25; 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 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 20ga x 2.25¿ accucath peripheral iv catheter.The sample was received with an attached extension tube.Usage residues were observed throughout the sample.A permanent kink impression was observed near the distal end of the catheter shaft.The sample kinked preferentially at the site of the kink impression during manual manipulation.Microscopic inspection of the sample confirmed the presence of kinked shape memory near the end of the catheter shaft.The catheter tip exhibited slight deformation.The kink impression and tip deformation were consistent with catheter kinking during attempted catheter advancement against resistance.The usage residues indicated that advancement occurred during attempted device placement.A lot history review (lhr) of recx3942 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that that one of the accucath ultrasound iv sets had a kink in the tubing and it was unable to be used.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20GX2.25
• 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: 8551791
• Report Number: 3006260740-2019-01158
• Device Sequence Number: 2292710
• Product Code: FOZ
• UDI-Device Identifier: 00801741111006
• UDI-Public: (01)00801741111006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/25/2019

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: AC0202252
• Device Lot Number: RECX3942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1