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

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Chest Pain (1776); Anxiety (2328); Radiation Exposure, Unintended (3164)

Event Date 01/08/2019

Event Type  malfunction  

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 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)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8375155
• MDR Text Key: 137686357
• Report Number: 3006260740-2019-00391
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3173108
• Device Lot Number: RECV0964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR