MAUDE Adverse Event Report: BECTON, DICKINSON, AND COMPANY / C. R. BARD, INC. POWERPICC SOLO PICC LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number 9295108D

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

Procedure began in right arm.Unable to pass picc through brachial line past 11cm.Difficult to remove line- seemed as though it vasospasmed.After waiting approximately 10 seconds, repositioned patient and again attempted to pass 11cm unsuccessfully.Basilic and cephalic are too small for picc on right arm.Moved to the left side.Maintained sterile field and found appropriate sized basilic vein.Continued with procedure.Line passes easily.Dressed per hospital protocol.Small wire fragment medial to the proximal shaft of right humerus.

• Brand Name: POWERPICC SOLO PICC LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON, AND COMPANY / C. R. BARD, INC.; franklin lakes NJ 07417
• MDR Report Key: 16337278
• MDR Text Key: 309295067
• Report Number: MW5114807
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9295108D
• Device Lot Number: REGW0942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White