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

Model Number N/A

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

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 the guidewire removing the flow actuator from the catheter was confirmed and the cause appeared to be use-related. The product returned for evaluation was one accucath peripheral iv catheter assembly. The catheter was not returned for evaluation. Usage residues were observed throughout the sample. The safety button was depressed and the needle was fully withdrawn into the housing. The wire exhibited a 90 degree bend approximately 2cm proximal of the coil. The coils were misaligned but appeared intact. The flow actuator was observed within the housing. Microscopic inspection of the sample confirmed that the wire was intact. Inspection of the flow actuator was unremarkable. The retention features appeared well-formed. It appeared that the removal of the flow actuator was caused by inability of the actuator to pass the bent region of the guidewire. The guidewire bent and coil misalignment was consistent with attempted guidewire advancement into tissue or through a tortuous path. The usage residue indicated that guidewire damage occurred during attempted device placement. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that upon retraction of accucath wire, it was observed that the wire caught on the blood control valve and pulled out the whole plastic part of the blood control valve. The catheter was removed and a new one was placed. No patient injury was reported. 1/22/2019 - returned wire is kinked.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8340889
• Report Number: 3006260740-2019-00252
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial