MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Aneurysm (1708); Vasculitis (2004)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - 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.
Event or Problem Description
It was reported the patient requested chemotherapy mainly due to breast cancer surgery for more than 3 months, came to our department on (b)(6) 2023, and was admitted to the hospital with "milk rock" in the outpatient clinic, and underwent the first intravenous chemotherapy on (b)(6) 2023, and underwent percutaneous transperipheral catheterization in our department.At the time of admission, the patient complained of earthworm-like varicose veins in the superficial blood vessels around the catheter, with superficial vein bulging and dilation, and peripheral induration chest x-ray re-examination on (b)(6) 2023: ectopic catheter.Phlebitis is considered to be caused by ectopic central venous catheters through peripheral teahouses.
Event or Problem Description
It was reported the patient requested chemotherapy mainly due to breast cancer surgery for more than 3 months, came to our department on (b)(6) 2023, and was admitted to the hospital with "milk rock" in the outpatient clinic, and underwent the first intravenous chemotherapy on (b)(6) 2023, and underwent percutaneous transperipheral catheterization in our department.At the time of admission, the patient complained of earthworm-like varicose veins in the superficial blood vessels around the catheter, with superficial vein bulging and dilation, and peripheral induration chest x-ray re-examination on (b)(6) 2023: ectopic catheter.Phlebitis is considered to be caused by ectopic central venous catheters through peripheral teahouses.
Additional Manufacturer Narrative
H11: section a through f - 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.
Additional Manufacturer Narrative
H11: section a through f - 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.
Event or Problem Description
It was reported the patient requested chemotherapy mainly due to breast cancer surgery for more than 3 months, came to our department on (b)(6) 2023, and was admitted to the hospital with "milk rock" in the outpatient clinic, and underwent the first intravenous chemotherapy on (b)(6) 2023, and underwent percutaneous transperipheral catheterization in our department.At the time of admission, the patient complained of earthworm-like varicose veins in the superficial blood vessels around the catheter, with superficial vein bulging and dilation, and peripheral induration chest x-ray re-examination on (b)(6) 2023: ectopic catheter.Phlebitis is considered to be caused by ectopic central venous catheters through peripheral teahouses.

• Brand Name: GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 18097075
• Report Number: 3006260740-2023-05081
• Device Sequence Number: 12449433
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(17)241231(10)REGS0788
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REGS0788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 06/18/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown