MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 Hickman CV Catheter, Triple-Lumen, 12.5F; Chronic Catheters

Catalog Number	0600650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records cannot be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.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.
Event or Problem Description
On (b)(6) 2026, the patient underwent a catheter placement procedure using hickman cv catheter, triple-lumen, 12.5f.Sometime post procedure, it was reported that the catheter had broken.There was no reported patient injury.
Event or Problem Description
On march 05, 2026, it was reported that an external catheter fracture was identified during routine care, and no medication was administered at the time the fracture was identified.Reportedly, the catheter line was isolated with sterile gauze and micropore tape.It was further reported that the patient expired due to unspecified causes.The relationship of the adverse event was determined to be not related to the device and not related to the reported external catheter fracture.
Additional Manufacturer Narrative
H11: based on the additional information was received from the customer indicating that the patient expired due to unspecified causes.The reported death was assessed and determined to be unrelated to the device and unrelated to the reported external catheter fracture.The date of death for this patient was not provided; therefore, the date of death has been updated as (b)(6) 1900 to meet the mdr submission requirement.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.One photo was provided and reviewed.The photo shows the partial view implanted catheter and physician was pointing the catheter damage.The blue extension leg was noted to be partially fractured.Therefore, the investigation is confirmed for the reported catheter fracture issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B2, b5, g3, h6 (component, method, result, conclusion).Section a through f: the information provide by bd represents all 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, Triple-Lumen, 12.5F
• 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: 24695183
• Report Number: 3006260740-2026-01953
• Device Sequence Number: 18669431
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 0600650
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 09/10/2026; 09/21/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 09/14/2026; 09/24/2026
• 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 Sex: Unknown