MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1194108D

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Anxiety (2328); Numbness (2415); Sweating (2444); Electric Shock (2554); Alteration In Body Temperature (2682)

Event Date 10/18/2017

Event Type  Injury  

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.A lot history review (lhr) of rebv0693 showed no other similar product complaint(s) from this lot number.[mw5075016.Pdf].

Event Description

Patient reported health issues related to the picc.The reported issues are: numbness and ongoing pain in arms and chest, electrical shocks, urinary tract infection, nausea, anxiety sweats, pelvic pain, chronic fatigue, low grade fever, and intermittent chills.Patient's primary care physician attributes her symptoms to "adjusting to the release of the antibiotics".Patient continues to schedule appointments with specialists.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7383948
• MDR Text Key: 103916368
• Report Number: 3006260740-2018-00560
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/31/2018,03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1194108D
• Device Catalogue Number: 1194108D
• Device Lot Number: REBV0693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2018
• Distributor Facility Aware Date: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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