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

Model Number F118100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/10/2020

Event Type  malfunction  

Event Description

The tip of a rfo-transducer tip detached from a midline catheter during it insertion on the patient.Following the incident, the patient has had multiple imaging studies done to try to locate rfo-transducer tip.Uf contacted the manufacturer of the powerglide pro midline catheter.Manufacturer sent a postage paid envelope for the return of the defective device.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT
• 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: 10118520
• MDR Text Key: 193967435
• Report Number: 10118520
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F118100
• Device Catalogue Number: F118100
• Device Lot Number: REDV1232
• 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: 05/26/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1