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.(b)(4).
Event or Problem Description
It was reported via medwatch "patient's peripheral iv unable to flush despite numerous attempts.Peripheral iv was pulled and noted to have a kink in it.Recurring problem.".
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 peripheral iv 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 and an extension set was attached to the luer adapter.Multiple permanent kink impressions were observed along the length of the catheter tubing.Microscopic inspection of the sample revealed deformation, buckling and material discoloration in the vicinity of the kinks.The sample kinked preferentially at the sites of the kink impressions during manual manipulation.The kink impressions were consistent with the catheter being subjected to sharp bends/kinks.The usage residue and event description suggested that kinking occurred during or following device placement.Such kinks can occur if insertion is attempted against resistance, such as into tissue or through a tortuous path.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 "patient's peripheral iv unable to flush despite numerous attempts.Peripheral iv was pulled and noted to have a kink in it.Recurring problem.".

• 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: 9090269
• Report Number: 3006260740-2019-02762
• Device Sequence Number: 11377372
• 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): 10/15/2019

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: 08/28/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 91