MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 CENTROVENA ONE; CENTRAL VENOUS CATHETERIZATION KIT, SHORT-TERM

Catalog Number	1MC0R7320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of 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.The date of event was not provided by the complainant/reporter; the date reflected in this report is the date bd became aware of the event.The failure was found during evaluation of a returned sample.Additional investigation is required to determine the cause of the failure.Results of the investigation are expected soon.
Event or Problem Description
It was found during a sample investigation that the needle tip appeared damaged.No further information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of 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.The complaint of a blunted needle tip was confirmed; however, the root cause was not identified.The product returned for evaluation was one centrovena one catheter insertion assembly and one 7fr by 20cm central venous catheter.The guidewire was removed from the needle.The sheath was cut and the safety mechanism was engaged over the needle tip.Blood residue was observed throughout the distal region of the needle and sheath.A portion of the tip of the sheath was torn and folded backward.This damage is addressed in trackwise complaint 14404763.The needle tip appeared blunted.Microscopic inspection of the sample confirmed needle tip damage.The tip of the needle exhibited deformation consistent with a facture, leaving the needle tip flat (see attached photographs).Microscopic inspection of the metal safety tip shield revealed light scoring marks, suggesting some contact with the needle tip.Inspection of the needle tip revealed that it appeared to have fractured; however, no evidence was observed that informed precisely when or how that fracture occurred.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: CENTROVENA ONE
• Common Device Name: CENTRAL VENOUS CATHETERIZATION KIT, SHORT-TERM
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24688277
• Report Number: 3006260740-2026-01982
• Device Sequence Number: 9770542
• Product Code: SEF
• UDI-Device Identifier: 00801741234729
• UDI-Public: (01)00801741234729(11)260130(17)270430(10)REKY2340
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K242429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 1MC0R7320
• Device Lot Number: REKY2340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2026
• 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: Other
• Patient Sex: Unknown