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 Thrombosis/Thrombus (4440)

Event Date 11/19/2022

Event Type  Injury  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported on (b)(6) 2022, under the guidance of b-ultrasound, a peripherally intubated central venous catheter was inserted from the basilic vein of the right upper limb into the superior vena cava for intravenous infusion of drugs to prevent extravasation of chemotherapy drugs.After the catheter is inserted, the catheter will be disinfected and changed every week, and the catheter will be flushed and other maintenance.For chemotherapy: from may 26, 2022 to july 29, 2022, 4 cycles of intravenous infusion of cyclophosphamide + doxorubicin + cisplatin chemotherapy will be given for the treatment of thymoma.On (b)(6) 2022, b-ultrasound of the veins of the left upper extremity was performed, indicating that the basilic vein, axillary vein, and subclavian vein indwelling catheters in the right side had undergone intracavitary catheterization, and the basilic vein and axillary vein catheterization had wall thrombosis.On (b)(6) 2022, anticoagulation therapy with low molecular weight heparin calcium 4000iu was started.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16200232
• MDR Text Key: 307660703
• Report Number: 3006260740-2023-00058
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7717405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention