MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1275108D

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Patient's vein was successfully cannulated with 21g steel needle.It was discovered then that the microintroducer would not thread through the end of the steel needle.Attempted again to thread wire through the needle without success.Separate microintroducer kit opened and procedure was completed without incident.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET MICROINTRODUCER
• 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: 11824652
• MDR Text Key: 250634832
• Report Number: 11824652
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1275108D
• Device Catalogue Number: 1275108D
• Device Lot Number: REEZ3754
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1