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

Model Number AC0202250

Device Problems Bent (1059); Sticking (1597)

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

Event Date 05/01/2017

Event Type  malfunction  

Event Description

New accucath opened and found with guidewire stuck and bent.Unable to use.Discovered before use on patient.Manufacturer response for intravascular catheter, accucath (per site reporter).No response at this time.

• Brand Name: ACCUCATH
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6581195
• MDR Text Key: 75667905
• Report Number: 6581195
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2017

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
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REAZ1460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1