MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9194118
Health Effect - Clinical Code	Chest Tightness/Pressure (2463)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of rebu0331 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was inserted via left arm basilica vein, initial difficulty in advancing the catheter as catheter was going to the right ij, eventually was able to direct catheter to distal svc, fibrin noted in catheter lumen, fibrin was withdrawn from syringe and syringe flushed with normal saline, dressing completed.Patient supposedly stated having chest pressure, vital signs stable, no shortness of breath.No apparent harm to the patient.

• Brand Name: POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7201200
• Report Number: 3006260740-2017-02445
• Device Sequence Number: 1177189
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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
• Operator of Device: Health Professional
• Device Model Number: 9194118
• Device Catalogue Number: 9194118
• Device Lot Number: REBU0331
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1