MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SL PICC (60 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7717405

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Phlebitis (2004); Thrombus (2101)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recw0194 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported the patient was admitted to the hospital for 1, rectal cancer (rectal cancer with multiple abdominal and pelvic metastasis, lung metastasis stage iv kras, nras wild type) 2, thrombophlebitis (thrombophlebitis of the left upper limb).Chemotherapy was performed on (b)(6) 2020 under the guidance of b-ultrasound to perform ¿deep venipuncture catheterization¿ in the important vein of the left upper limb.The procedure was smooth, the catheterization depth was 43cm, and the catheter opening was free of blood or fluid.Pressure bandaged, no complaints of discomfort.The arm circumference of the left upper limb is 23cm.On november 6th, he was admitted to the hospital for specialist treatment.The patient complained of swelling and pain in his left upper extremity, no mobility, no numbness, and color doppler ultrasound showed that the left upper extremity venous thrombosis and phlebitis.Follow the doctor's instructions to subcutaneously inject 0.4ml of low molecular weight heparin calcium injection for symptomatic treatment.The drug was used until (b)(6) and there was no bleeding, exudation, redness, and discomfort at the catheter site.

• Brand Name: GROSHONG 4F SL PICC (60 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11061841
• MDR Text Key: 224313641
• Report Number: 3006260740-2020-21045
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7717405
• Device Catalogue Number: 7717405
• Device Lot Number: RECW0194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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 Outcome(s): Other