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 Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the hickman catheter.It was reported that, 1 month and 11 days post chronic catheter placement, the catheter allegedly leaked from exit site, on (b)(6) 2025.It was further reported that this resulted in injury or impairment requiring medical intervention.On (b)(6) 2025, the device was explanted.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/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) 2025, a patient underwent a chronic catheter placement procedure using the hickman catheter.It was reported that 1 month and 11 days post a chronic catheter placement, the catheter allegedly leaked from exit site on (b)(6) 2025.It was further reported that this resulted in injury or impairment requiring medical intervention.On (b)(6) 2025, the device was explanted.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 10fr hickman t/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe was attached to the blue luer and was patent to infusion and aspiration.An in-house syringe was attached to the red luer and was patent to infusion and aspiration.An in-house syringe was attached to the white luer.Upon infusion, what appeared to be a small bubble from a pinhole, was noted on the center portion of the catheter body, proximal to the tied suture wire ,what appeared to be two bubbles from a pinhole in parallel, was noted on the catheter body, proximal to the tied suture wire when infusing the white luer.Therefore ,the investigation is confirmed for the reported fluid leak and identified material puncture/hole issues.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D1, d4 (medical device catalog #, medical device lot #, medical device expiration date, unique identifier (udi) #), g3, g4, h6 (method).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) 2025, a patient underwent a chronic catheter placement procedure using the hickman catheter.It was reported that 1 month and 11 days post a chronic catheter placement, the catheter allegedly leaked from exit site on (b)(6) 2025.It was further reported that this resulted in injury or impairment requiring medical intervention.On (b)(6) 2025, the device was explanted.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 10fr hickman t/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe was attached to the blue luer and was patent to infusion and aspiration.An in-house syringe was attached to the red luer and was patent to infusion and aspiration.An in-house syringe was attached to the white luer.Upon infusion, what appeared to be a small bubble from a pinhole, was noted on the center portion of the catheter body, proximal to the tied suture wire ,what appeared to be two bubbles from a pinhole in parallel, was noted on the catheter body, proximal to the tied suture wire when infusing the white luer.Therefore ,the investigation is confirmed for the reported fluid leak and identified material puncture/hole issues.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G2, g3, h6 (device, component, method, result).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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22584896
• Report Number: 3006260740-2025-05132
• Device Sequence Number: 14575009
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975(11)250415(17)300328(10)HUKR0077
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2025

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 Catalogue Number: 0600650
• Device Lot Number: HUKR0077
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/24/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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