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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
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 difficult accucath guidewire advancement 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 assembly.The sample was received fully assembled.Usage residues were observed throughout the sample.An attempt to advance the guidewire was initially unsuccessful.The wire was eventually successfully advanced against resistance.Coil tip deformation appeared to be the cause of the resistance to wire advancement.Microscopic inspection of the guidewire confirmed abundant deformation/kinking throughout the coil region.The guidewire was intact.Both blood product residue within the needle shaft and the deformation of the guidewire coil tip appeared to be the cause of the observed resistance to wire advancement.The wire deformation was consistent with attempted advancement against resistance, such as into tissue, and the blood residue indicated that occurred during attempted device insertion.A lot history review (lhr) of reeq4025 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion, the wire wouldn't advance.A new device was placed.Additional information received 8/21/2020: it was reported the picc was placed in the left basilic vein in the upper arm.There was no patient harm or any extensive tissue damaged.It was determined that the returned device was found kinked during evaluation.

• Brand Name: ACCUCATH, 18 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10581316
• Report Number: 3006260740-2020-03335
• Device Sequence Number: 2627332
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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 Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: AC0182250
• Device Lot Number: REEQ4025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 54