MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN,12F; CHRONIC CATHETERS

Model Number	0600620
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that seven months and four days post chronic catheter placement procedure in the right internal jugular vein, the device allegedly fractured.It was further reported that lumen allegedly blocked during flushing.The device was repaired.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 12fr hickman d/l catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed.The investigation is confirmed for the reported leak, fracture, obstruction of flow and identified burst issues as a c-shaped split was noted on the white luer extension leg approximately 1.0cm from the clamping sleeve.A longitudinal split was noted on the red luer extension leg approximately 0.6cm from the clamping sleeve.During tactile evaluation, extension legs and catheter were gently stretched and necking was observed throughout.All areas were noted to be normally elastic.Upon infusion of the white luer, a leak from the c-shaped split was noted while water exited the distal end of the catheter; only air was aspirated into the syringe.Thrombus was observed exiting the catheter on both infusion attempts.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, g3, h6(device, method).H11: h6(result, conclusion).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.H3 other text : see h10.
Event or Problem Description
It was reported that approximately seven months post chronic catheter placement procedure in the right internal jugular vein, the device allegedly fractured.It was further reported that lumen allegedly blocked during flushing.Reportedly leak was noted on the white luer of the catheter.The device was repaired.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN,12F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13629129
• Report Number: 3006260740-2022-00534
• Device Sequence Number: 5913178
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female