MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH 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	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu3823 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, "on (b)(6) 2020, patients with appendix cancer in the second area of the tumor used a peripherally intubated central venous catheter from the upper right limb to the superior vena cava using a peripherally intubated central venous catheter for intravenous infusion of drugs to prevent extravasation of chemotherapy drugs.After the catheter is inserted, the catheter should be disinfected and changed every week, and the tube flushed for maintenance.For chemotherapy: on (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, intravenous infusion of oxaliplatin + oral capecitabine chemotherapy.Used to treat malignant tumors of the appendix.He returned to the hospital on (b)(6) 2021, and the patient complained of swelling and pain in his right upper arm.Then, a b-ultrasound examination of the right upper limb vein (b)(6) 2021, examination number: 2581783) showed that mural thrombosis was seen at the end of the indwelling tube after the indwelling tube in the right side of the main vein, axillary vein, and subclavian vein.Starting from (b)(6) 2021, low molecular weight heparin calcium 5000iu for injection, once every 12 hours, subcutaneous injection of anticoagulant therapy, after the vascular surgery consultation, oral rivaroxaban 15mg on (b)(6) 2021, anticoagulant treatment is given once a day.".

• Brand Name: PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH 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
• MDR Report Key: 11398539
• Report Number: 3006260740-2021-00590
• Device Sequence Number: 19975562
• 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): 02/05/2021

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 Model Number: N/A
• Device Catalogue Number: 4134115
• Device Lot Number: REDU3823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR