MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC W/SAFETY EXCALIBUR INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, due to the need for chemotherapy, a peripherally intubated central venous catheter was used to insert the central venous catheter from the right upper extremity into the superior vena cava under the guidance of b-ultrasound for intravenous infusion of drugs to prevent extravasation of chemotherapy drugs.After the catheter is placed, the catheter should be sterilized, changed, and cleaned every week for maintenance.For chemotherapy: 2 cycles of endostatin therapy on (b)(6) 2021 and (b)(6) 2021, 2 cycles of chemotherapy starting on (b)(6) 2021, and (b)(6) 2021, the specific dose is: more sitaxel + carboplatin.For the treatment of lung cancer.On (b)(6) 2021, he was returned to the hospital and the patient complained of swelling, pain and discomfort in the right upper arm.The b-ultrasound of the right upper extremity vein showed thrombosis of the right subclavian vein indwelling tube.After consultation with vascular surgery, oral rivaroxaban 10 mg was added on (b)(6) 2021, once a day for anticoagulation.
Additional Manufacturer Narrative
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: PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC W/SAFETY EXCALIBUR INTRODUCER
• Common Device Name: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13373043
• Report Number: 3006260740-2022-00090
• Device Sequence Number: 3263298
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• 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
• Report Date (Section B): 01/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 4134115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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