MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Hickman CV Catheter, Dual-Lumen, 7F; Chronic Catheters

Catalog Number	0600570
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a catheter placement procedure using a hickman/leonard/broviac central venous catheter.After a period of use, on (b)(6) 2026, inadequate securement and line management, along with continuous stretching, twisting, and kinking of the line, resulted in an almost complete tear/rupture of the white lumen of the dual lumen tunneled line.It was further reported that the issue was identified when blood leakage was observed on the bed.The catheter was subsequently repaired using a repair kit.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.However, the return of the sample is pending.The investigation of the reported event is currently underway.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: Hickman CV Catheter, Dual-Lumen, 7F
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50468916
• Report Number: 3006260740-2026-06231
• Device Sequence Number: 13304970
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869(17)300328(10)HUKW0527
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Catalogue Number: 0600570
• Device Lot Number: HUKW0527
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 3 YR
• Patient Sex: Unknown