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	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2023
Type of Reportable Event	Malfunction
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 was admitted to the oncology department of our hospital as "coughing up sputum and shortness of breath for more than 5 months, and 20 days after the first cycle of chemotherapy after radiotherapy for lung cancer", and now in order to seek further anti-tumor treatment, the outpatient clinic is admitted to the oncology department of our hospital with "lung cancer".Preliminary diagnosis: 1.Upper lobe squamous cell carcinoma of the left lung with mediastinal and bilateral hilar lymph node metastasis (ct4n3m0, stage iii.B) after radiotherapy; 2.Maintenance chemotherapy for malignant tumors; 3.Reflux esophagitis; 4.Functional dysphagia; 5.Lung abscess; 6.Obstructive pneumonia; 7.Hyperlipidemia; 8.Chronic gastritis; 9.Pulmonary embolism?; 10.Kidney stones; 11.Kidney cysts.Tc chemotherapy was given, paclitaxel (albumin-bound) 350mg ivgtt d1 + carboplatin 330mg ivgtt, q3w.He was given acid suppression, antiemetic and hepatoprotective therapy during chemotherapy, and began to use picc catheter infusion chemotherapy drugs through peripheral intubation (b)(6) 2023.When the patient is punctured, the guidewire of the central venous catheter picc through the peripheral cannula is discounted and bifurcated, and the puncture cannot be punctured normally, resulting in puncture failure, because the puncture catheter is not performed in time, and the puncture needs to be re-performed, resulting in the patient's chemotherapy drugs not being entered on time, due to the long repeated puncture time, the chemotherapy drugs are postponed for infusion on the second day, which increases the patient's pain, prolongs the treatment time, aggravates the patient's condition, and there is a risk of cancer at any time.If the problem is found, stop using it immediately, (take measures): 1.Immediately replace the new central venous catheter picc through peripheral intubation to re-puncture the catheter for the patient; 2.Give diphenhydramine hydrochloride injection 20mg to stop emetic; 3.Follow the doctor's advice to place the ecg monitor, closely observe the patient's vital signs, and closely observe the patient's condition.
Event or Problem Description
It was reported the patient was admitted to the oncology department of our hospital as "coughing up sputum and shortness of breath for more than 5 months, and 20 days after the first cycle of chemotherapy after radiotherapy for lung cancer", and now in order to seek further anti-tumor treatment, the outpatient clinic is admitted to the oncology department of our hospital with "lung cancer".Preliminary diagnosis: 1.Upper lobe squamous cell carcinoma of the left lung with mediastinal and bilateral hilar lymph node metastasis (ct4n3m0, stage iii.B) after radiotherapy; 2.Maintenance chemotherapy for malignant tumors; 3.Reflux esophagitis; 4.Functional dysphagia; 5.Lung abscess; 6.Obstructive pneumonia; 7.Hyperlipidemia; 8.Chronic gastritis; 9.Pulmonary embolism?; 10.Kidney stones; 11.Kidney cysts.Tc chemotherapy was given, paclitaxel (albumin-bound) 350mg ivgtt d1 + carboplatin 330mg ivgtt, q3w.He was given acid suppression, antiemetic and hepatoprotective therapy during chemotherapy, and began to use picc catheter infusion chemotherapy drugs through peripheral intubation on (b)(6) 2023.When the patient is punctured, the guidewire of the central venous catheter picc through the peripheral cannula is discounted and bifurcated, and the puncture cannot be punctured normally, resulting in puncture failure, because the puncture catheter is not performed in time, and the puncture needs to be re-performed, resulting in the patient's chemotherapy drugs not being entered on time, due to the long repeated puncture time, the chemotherapy drugs are postponed for infusion on the second day, which increases the patient's pain, prolongs the treatment time, aggravates the patient's condition, and there is a risk of cancer at any time.If the problem is found, stop using it immediately, (take measures): 1.Immediately replace the new central venous catheter picc through peripheral intubation to re-puncture the catheter for the patient; 2.Give diphenhydramine hydrochloride injection 20mg to stop emetic; 3.Follow the doctor's advice to place the ecg monitor, closely observe the patient's vital signs, and closely observe the patient's condition.
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 was admitted to the oncology department of our hospital as "coughing up sputum and shortness of breath for more than 5 months, and 20 days after the first cycle of chemotherapy after radiotherapy for lung cancer", and now in order to seek further anti-tumor treatment, the outpatient clinic is admitted to the oncology department of our hospital with "lung cancer".Preliminary diagnosis: 1.Upper lobe squamous cell carcinoma of the left lung with mediastinal and bilateral hilar lymph node metastasis (ct4n3m0, stage iii.B) after radiotherapy; 2.Maintenance chemotherapy for malignant tumors; 3.Reflux esophagitis; 4.Functional dysphagia; 5.Lung abscess; 6.Obstructive pneumonia; 7.Hyperlipidemia; 8.Chronic gastritis; 9.Pulmonary embolism?; 10.Kidney stones; 11.Kidney cysts.Tc chemotherapy was given, paclitaxel (albumin-bound) 350mg ivgtt d1 + carboplatin 330mg ivgtt, q3w.He was given acid suppression, antiemetic and hepatoprotective therapy during chemotherapy, and began to use picc catheter infusion chemotherapy drugs through peripheral intubation on september 23, 2023.When the patient is punctured, the guidewire of the central venous catheter picc through the peripheral cannula is discounted and bifurcated, and the puncture cannot be punctured normally, resulting in puncture failure, because the puncture catheter is not performed in time, and the puncture needs to be re-performed, resulting in the patient's chemotherapy drugs not being entered on time, due to the long repeated puncture time, the chemotherapy drugs are postponed for infusion on the second day, which increases the patient's pain, prolongs the treatment time, aggravates the patient's condition, and there is a risk of cancer at any time.If the problem is found, stop using it immediately, (take measures): 1.Immediately replace the new central venous catheter picc through peripheral intubation to re-puncture the catheter for the patient; 2.Give diphenhydramine hydrochloride injection 20mg to stop emetic; 3.Follow the doctor's advice to place the ecg monitor, closely observe the patient's vital signs, and closely observe the patient's condition.
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.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18012798
• Report Number: 3006260740-2023-04865
• Device Sequence Number: 7469315
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(17)241231(10)REGT4259
• 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): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: REGT4259
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 10/26/2023
• 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: 06/01/2022
• 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: Other
• Patient Sex: Unknown