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

Model Number 1174108D5

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

Event Description

Rubber stopper on single-lumen picc leaks saline when flushed.

Event Description

Rubber stopper on single-lumen picc leaks saline when flushed.

• 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: 16784739
• MDR Text Key: 313727173
• Report Number: 16784739
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155147
• UDI-Public: (01)00801741155147
• 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,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1174108D5
• Device Catalogue Number: 1174108D5
• Device Lot Number: REGZ0989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male
• Patient Weight: 96 KG