MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, TRIPLE-LUMEN, 10F; CHRONIC CATHETERS

Catalog Number	0606560CE
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Erythema (1840); Extravasation (1842); Pain (1994); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The return of the sample is pending.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 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 hickman triple lumen catheter.On (b)(6) 2025, one month and five days later post chronic catheter placement, the device was allegedly leaking with blood following flushing.It was further reported that the line was allegedly found burst.On (b)(6) 2025, the device was removed.Reinsertion of tunneled cvc to complete treatment.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.The catalog number identified in section d4 has not been cleared in the us but is similar to the hickman cv catheter products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter products are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.B1, b5, d4 (medical device catalog #), g3, h1, h6 (patient, device, component, method).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 device was inserted.On j(b)(6) 2025 a patient underwent for a chronic catheter placement procedure using hickman cv catheter, triple-lumen, 10f.Post the procedure, the device was allegedly leaking with blood following flushing.It was further reported that the line was allegedly found burst.On (b)(6), the device was removed.Reinsertion of tunneled cvc to complete treatment.Reportedly, patient allegedly experienced pain, redness, swelling, extravasation and white lumen was allegedly had a visible hole.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the hickman cv catheter products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter products are identified in d2 and g4.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 and three electronic photos were provided for review.A longitudinal split was noted on the distal portion of the white luer extension leg.The edges of the longitudinal split on the white luer extension leg were noted to be uneven.Residue was noted throughout split area.Upon infusion, small resistance was felt while a leak from the longitudinal split on the distal end of the extension leg was observed.Therefore, the investigation is confirmed for the reported fracture and fluid leak issues.However, it is unconfirmed for the reported material puncture/hole as more specific damages fracture and fluid leak issues were confirmed during investigation.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.G3, h6 (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 device was inserted.On (b)(6) 2025 a patient underwent for a chronic catheter placement procedure using hickman cv catheter, triple-lumen, 10f.Post the procedure, the device was allegedly leaking with blood following flushing.It was further reported that the line was allegedly found burst.On (b)(6), the device was removed.Reinsertion of tunneled cvc to complete treatment.Reportedly, patient allegedly experienced pain, redness, swelling, extravasation and white lumen was allegedly had a visible hole.The current status of the patient was unknown.
Event or Problem Description
On (b)(6) 2025 the device was inserted.On (b)(6) 2025, a patient underwent for a chronic catheter placement procedure using hickman cv catheter, triple lumen, 10f.Post the procedure, the device was allegedly leaking with blood following flushing.It was further reported that the line was allegedly found burst.On july 8, the device was removed.Reinsertion of tunneled cvc to complete treatment.Reportedly, patient allegedly experienced pain, redness, swelling, extravasation and white lumen was allegedly had a visible hole.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the hickman cv catheter products that are cleared in the us.The pro code and 510 k number for the hickman cv catheter products are identified in d2 and g4.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 and 3 electronic photos were provided for review.A longitudinal split was noted on the distal portion of the white luer extension leg.The edges of the longitudinal split on the white luer extension leg were noted to be uneven.Residue was noted throughout split area.Upon infusion, small resistance was felt while a leak from the longitudinal split on the distal end of the extension leg was observed.It appears there is a very significant protrusion from one side of the burst that overlapping the other side.Therefore, the investigation is confirmed for the reported fluid leak and identified catheter burst issues.However, the investigation is unconfirmed for the reported fracture and material puncture/hole issues as more appropriate catheter burst code has been identified.A definitive root cause could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (device, component, 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, 10F
• 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: 22749958
• Report Number: 3006260740-2025-05667
• Device Sequence Number: 8607154
• Product Code: LJS
• UDI-Device Identifier: 00801741052019
• UDI-Public: (01)00801741052019(11)250224(17)290828(10)HUKN1334
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2026

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 Catalogue Number: 0606560CE
• Device Lot Number: HUKN1334
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/15/2025; 02/13/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/22/2025; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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