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

Catalog Number	0609270
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.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.
Event or Problem Description
On (b)(6) 2026, the patient underwent a catheter placement procedure using the hickman trifusion central venous catheter.During the procedure, the plastic piece covering the connection point between the tunneler and the catheter reportedly slid off the tunneler and traveled down the catheter beneath the patient¿s skin, resulting in a foreign body left inside the patient.It was further reported that the patient experienced discomfort with the tunneled line.The current patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 27fr trifusion t/l catheter was returned for evaluation.Visual, microscopic visual evaluations were performed on the returned device.The distal end of the sheath appeared to be fractured as the end appeared to be missing material pieces.The edges of the distal tip appeared to be uneven as it appeared as an upside down v.Therefore, the investigation is confirmed for device dislodged or dislocated and identified fracture and material separation.However, it is inconclusive for the reported migration issue as supporting evidence for the reported migration is not available.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.B3, b5, e1, g3, h6 (device, component, method, result, conclusion).Section a through f: the information provided 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.
Event or Problem Description
On (b)(6) 2025, the patient underwent a catheter placement procedure using the hickman trifusion central venous catheter.During the procedure, the plastic piece that covers the connection point between the tunneler and the catheter reportedly slid off the tunneler and traveled down the catheter beneath the patient¿s skin, resulting in a foreign body left inside the patient.It was further reported that the patient experienced discomfort with the tunneled line, and a foreign body was removed from the patient.The current status of the patient is unknown.

• Brand Name: HICKMAN TRIFUSION CV CATHETER
• 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 REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24495000
• Report Number: 3006260740-2026-01337
• Device Sequence Number: 18801216
• Product Code: LJS
• UDI-Device Identifier: 00801741036545
• UDI-Public: (01)00801741036545(17)260331(10)REJR3880
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 0609270
• Device Lot Number: REJR3880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown