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

Model Number N/A

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

Patient Problem Thrombus (2101)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx4291 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported, "on (b)(6) 2020, the patient used a peripherally intubated central venous catheter kit and accessories 7717405 (three-way valve picc kit) from the right upper limb to the superior vena cava for intravenous drip.Drugs to prevent extravasation of chemotherapy drugs.After the catheter is inserted, the catheter should be disinfected and changed every week, and the tube flushed for maintenance.For chemotherapy: (b)(6) 2020, 5-27 infusion of pemetrexed + carboplatin for 2 cycles; (b)(6) 2020, 7-10, 08-01, 8-27 infusion of bevacizumab + pemetrexed + carboplatin; bevacizumab + pemetrexed instilled on (b)(6) 2020, 11-19 for infusion of human vascular endothelium in the focus group inhibin d1-7 + docetaxel d5 + nedaplatin d5; used to treat lung malignant tumors.On (b)(6) 2020, he returned to the hospital and was hospitalized.The patient complained of swelling, pain and discomfort in his right upper arm, edema in his right upper arm, and stiff skin on the touch.A b-ultrasound examination of the veins of the right upper limb ((b)(6) 2020, examination number: (b)(6)) showed that after the indwelling tube in the right vein, axillary vein, and subclavian vein, the vein thrombosis occurred.From (b)(6) 2020 to (b)(6)2020, 5000iu low-molecular-weight heparin calcium for injection, once every 12 hours, subcutaneously injected anticoagulant therapy, on (b)(6) 2020, review the right upper limb vein and upper brachial vein part of the thrombosis, oral administration of 15mg rivaroxaban, 2 times a day, continue anticoagulation therapy.".

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC (60CM)
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11112653
• MDR Text Key: 226320598
• Report Number: 3006260740-2020-21161
• 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: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 7717405
• Device Lot Number: RECX4291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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
• Patient Age: 34 YR