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 Unspecified Infection (1930)

Event Date 10/11/2022

Event Type  Injury  

Event Description

It was reported the patient underwent submental lymph node biopsy in our hospital on (b)(6) 2022.The pathological consultation showed that the lesions tended to be b-cell lymphoma in combination with he morphology and immunohistochemical results.On (b)(6) 2022, chop chemotherapy was performed, and the seventh chop chemotherapy was performed.After chemotherapy, he was discharged from hospital on march 24.Now i am admitted to our hospital at 11:16 on (b)(6) 2022 for re-chemotherapy.After completing the relevant examinations according to the doctor's advice, i will use a picc tube for chemotherapy at about 10:00 on (b)(6), the patient developed fever during the picc tube chemotherapy., mental illness and other conditions, the doctor initially suspected that the infection may be caused by the placement of the picc tube, the doctor gave nutritional support such as albumin infusion, and the picc tube was removed, and the patient's condition gradually improved.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reey0888 showed no other similar product complaint(s) from this lot number.

• 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: 15845140
• MDR Text Key: 304124500
• Report Number: 3006260740-2022-05464
• 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: 11/15/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 7717405
• Device Lot Number: REEY0888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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