MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F; CHRONIC CATHETERS

Catalog Number	0600560
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
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 that are cleared in the us.The pro code and 510 k number for the hickman cv catheter are identified in d2 and g4.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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/leonard/broviac central venous catheter.6 months and 2 days post placement procedure, a crack allegedly developed.During flushing after administration, the line allegedly clogged and flush fluid was observed bubbling out.And liquid suddenly squirted out of the flush.The issue was resolved after repair.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the hickman/leonard/broviac central venous catheter.On (b)(6) 2025, post placement procedure, a crack allegedly developed.During flushing after administration, the line reportedly became clogged, and flush fluid was observed bubbling and subsequently squirting out of the catheter.The issue was resolved following repair of the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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 hickman s/l catheter was returned for sample evaluation.Visual, microscopic visual and functional evaluations were performed.A c shape split was noted to the catheter body distal to the clamping sleeve and a projection from the lower end of the material within the burst was noted.The break surface of the c shaped spit was noted to be finely granular.An in house 10ml syringe was used to flush the catheter.Dye water was noted to exit from the distal set of splits.Therefore, the investigation is confirmed for the reported difficult to flush, air and gas issue, fluid leak and identified burst issue.The investigation is unconfirmed for the reported fracture issue as more specified burst issue was identified.The investigation is inconclusive for the reported obstruction of flow as complete catheter segment was not received and the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.The definitive root cause could not be determined based upon available information.Labelling 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, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a chronic catheter placement procedure using the hickman/leonard/broviac central venous catheter.On (b)(6) 2025, post placement procedure, a crack allegedly developed.During flushing after administration, the line reportedly became clogged, and flush fluid was observed bubbling and subsequently squirting out of the catheter.The issue was resolved following repair of the catheter.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 is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.B5, d4 (medical device catalog #, medical device lot #), g3, 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.

• Brand Name: HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F
• 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: 24342739
• Report Number: 3006260740-2026-00862
• Device Sequence Number: 18619890
• Product Code: LJS
• UDI-Device Identifier: 00801741051845
• UDI-Public: (01)00801741051845(17)290228(10)HUJY0221
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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: 0600560
• Device Lot Number: HUJY0221
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/16/2026; 03/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/02/2026
• 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
• Patient Sex: Unknown