MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Chest Pain (1776); Anxiety (2328); Radiation Exposure, Unintended (3164)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv0964 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (recv0964) have been reported from the same facility.
Event or Problem Description
It was reported that the " picc line unable to be removed at the bedside, picc placed in the right basilic vein, resistance met after 15-20cms removed, bedside team attempted warm compresses, relaxation (walking, normal activities, etc), cxr confirmed tip in axila and no knots or loops in line, pt referred to ir, no harm to patient however pt complained of chest pain after initial removal attempt, line remained patent during entire dwell time, no cath flo, on clindamycin, rocephen, and vancomycyn, no additional line needed.Line successfully removed in ir with a wire inserted in the single lumen.Pt was exposed to fluro during ir removal.Dr.In special procedures removed line without complication or sedation.Ir referral unavailable until next day ¿ pt sent back home with line partially removed and dressed, patient and parents expressed anxiety during timeframe.".

• Brand Name: POWERPICC SV CATHETER 3F FULL TRAY (SINGLE-LUMEN)
• 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: 8375155
• Report Number: 3006260740-2019-00391
• Device Sequence Number: 419858
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: N/A
• Device Catalogue Number: 3173108
• Device Lot Number: RECV0964
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR