MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 CENTROVENA ONE; CENTRAL VENOUS CATHETER (CVC)

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, patient wouldn¿t lay flat- propped up due to condition.They tried axillary subclavian- ij not available due to tubing etc couldn¿t access.He was having trouble getting needle through vein- could see the vein and artery on ultrasound but needle wouldn¿t penetrate the vein.He pulled back and tried to reinsert in the vein and then he removed the catheter completely- when he pulled it back he saw the bur.He tried to thread the guidewire and he met resistance.After he met resistance he pulled the guidewire back, tried to reposition the needle a little bit.Clinician inserted needle and was having issues getting through tissue.Proceeded to insert and encountered issues threading guidewire.Second insertion was a breeze- didn¿t use the same puncture site but was near.No patient harm, injury, complication or negative outcome.
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 difficult centovena one insertion 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.Microscopic inspection of the sample confirmed deformation at the distal tip of the sheath.Two parallel, longitudinally aligned split were observed, corresponding to the width of the needle channel.The splits resulted in a flap of sheath material that peeled away from the needle.The tip of the sheath appeared well-formed.The spacing between the two longitudinal splits suggested that buckling occurred where the needle slot leaves the sheath without support.Such damage may occur if the guidewire is not withdrawn into the needle shaft prior to insertion.The product ifu states ¿failure to retract the guidewire into the needle may result in damage to the integrated sheath.¿.

• Brand Name: CENTROVENA ONE
• Common Device Name: CENTRAL VENOUS CATHETER (CVC)
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24583644
• Report Number: 3006260740-2026-01571
• Device Sequence Number: 9084328
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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 Model Number: N/A
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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 Age: 30 YR
• Patient Sex: Unknown