MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 7F; CHRONIC CATHETERS

Catalog Number	0600570
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a catheter placement procedure using a hickman/leonard/broviac central venous catheter.9 months and 17 days post procedure, the patient got caught very slightly on the infusion cable and the hickman catheter was torn distally at the v-cuff, causing blood to flow out of the torn catheter.It was further reported that there was bleeding from the catheter, which fortunately could be stopped by clamping.The catheter had to be surgically removed.The current status of the patient is unknown.
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 return of the sample is pending.However, photo was provided for review.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.
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 7fr hickman d/l catheter in two segments, strengthening sheath and catheter body segment were returned.Along with return sample one photo was provided for the review.Gross, visual, microscopic visual, tactile and functional evaluations were performed.A complete circumferential break was noted on the proximal end of the strengthening sheath.Two splits were noted proximal to the tissue cuff.The edges of the complete circumferential break on the proximal end of the strengthening sheath were noted to be uneven, and surface was noted to be finely granular with residue throughout.The surface of the splits could not be determined as additional damage would be caused in area.Upon infusion, a leak from the splits was observed.Break and separation noted in photo review.Therefore, the investigation is confirmed for the reported fracture, separation and leak 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.B5, 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 male patient underwent a catheter placement procedure using a hickman/leonard/broviac central venous catheter.Post the procedure on (b)(6) 2025, the patient got caught very slightly on the infusion cable and the hickman catheter was torn distally at the v-cuff, causing blood to flow out of the torn catheter.It was further reported that the catheter was completely torn out.There was bleeding from the catheter, which was fortunately controlled by clamping.The catheter had to be surgically removed.The current status of the patient is unknown.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 7F
• 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: 23713607
• Report Number: 3006260740-2025-09280
• Device Sequence Number: 10406373
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869(17)280828(10)HUHY1113
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/17/2026

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: 0600570
• Device Lot Number: HUHY1113
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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 Age: 5 YR
• Patient Sex: Male