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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); Skin Inflammation/ Irritation (4545)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw4267 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient was placed in the left upper arm picc on (b)(6) 2022, and the blood was returned to the patient's left upper arm through two-person aspiration and bolus injection.After intravenous bolus injection of dexamethasone sodium phosphate, intravenous infusion of gastric protection, antiemetic and rehydration was performed, and no oozing fluid was found.At 17:09, chemotherapy with irinotecan was pumped through picc, and the infusion pump controlled the speed to 125ml/h, and no blood or exudate was seen; at 18:00, the nurses found blood exudate in the dressing of the patient, and the infusion was suspended immediately.Irinotecan was found to be the loose joint of the catheter and aircraft wing.The patient's skin was treated and disinfected according to the chemotherapy drug leakage process, and the catheter and aircraft wing connector was re-fixed, picc was stopped, and chemotherapy was suspended.On the 22nd, members of the static therapy team checked the patient's picc again, and confirmed that the leakage of chemotherapy drugs was caused by the loose joint of the aircraft wing.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• 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: 15811078
• MDR Text Key: 303793156
• Report Number: 3006260740-2022-05335
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• 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: 11/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REFW4267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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