MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) POWER PICC SOLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM

Lot Number REXJ1297

Device Problems Retraction Problem (1536); Component Missing (2306); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

During picc insertion, was inserting picc with sherlock wire into sheath.Sherlock sensor indicated picc was not advancing into svc as expected.Withdrew sherlock wire, wire would not retract.Advanced picc, was then able to retract wire.Inserted stiff wire into picc, advanced catheter easily over stiff wire.Examined tip of sherlock wire to re-insert for tip placement confirmation, noted that magnetic tip was missing from sherlock wire.Retracted picc, capped dilator and replaced it into sheath.Flushed picc catheter to determine if magnetic tip fragment was inside, tip not found.Informed md, obtained stat shoulder x-ray, revealing tip fragment overlying expected area of axillary vein.

• Brand Name: POWER PICC SOLO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM
• Manufacturer (Section D): C.R. BARD, INC. (BASD); 730 central ave.; murray hill NJ 07974
• MDR Report Key: 3586907
• MDR Text Key: 4164244
• Report Number: 3586907
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2014

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: Nurse
• Device Lot Number: REXJ1297
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2014
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 43