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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 09/28/2022

Event Type  Injury  

Event Description

It was reported the patient underwent picc catheterization chemotherapy for breast cancer on (b)(6) 2022.Due to the poor vascular condition of the patient, the catheterization site was 12 cm above the left elbow, and the arm was measured internally.Chemotherapy was performed on (b)(6) 2022.Infusion started at 9:00, local dressing was checked to be normal, and 750ml of fuzhi and other drugs were injected.Infusion was normal, and the infusion ended at 12:00, waiting for chemotherapy drugs.At 13:10, the infusion of chemotherapy drugs was found to be not smooth, and a slight resistance was found in the flushing of ns tube.After flushing, the patient returned to normal, that is, 0.9%sn100ml+ epirubicin 118mg80 drops/minute, and the infusion was finished at 13:35, and the flushing of ns100ml was given.After about ns20ml infusion, the patient complained of hand distension.The nurse immediately looked at the puncture site beside the bed and found mild swelling about 3cm above the puncture site and a small amount of light red fluid exudating at the puncture site of the picc dressing.The picc specialist nurse of the department was immediately instructed.Trachoma was found in the catheter about 1cm after the catheter was withdrawn.The picc catheter was immediately pulled out and injected with lidocaine 0.1g+ dexamethasone injection 5mg, plus ruyi huangjin powder for external application and local ice application.This condition did not cause adverse effects to the patient.

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.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
• 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: 15708002
• MDR Text Key: 302771279
• Report Number: 3006260740-2022-04206
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• 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: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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: 7655405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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