MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1174108D3

Device Problem Material Fragmentation (1261)

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

Event Date 11/05/2018

Event Type  malfunction  

Event Description

At start of picc procedure the needle was inserted in the vein.A blood return was seen when the needle entered the vein as expected.Suddenly the needle broke in "the w" separate pieces.I was able to remove the broken needle from the patient completely.Bard lot recq0277.Manufacturer response for catheter,intravascular,therapeutic,long-term greater than 30 days, powerpicc (per site reporter).

• Brand Name: POWERPICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8159333
• MDR Text Key: 130174703
• Report Number: 8159333
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2018

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: Health Professional
• Device Model Number: 1174108D3
• Device Catalogue Number: 1174108D3
• Device Lot Number: RECQ0277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA