MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER

Model Number 5733690

Device Problems Fracture (1260); Material Separation (1562); Separation Failure (2547); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 06/2024)/.H11: 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 Description

It was reported that prior to a dialysis catheter placement procedure in the right internal jugular vein, the healthcare personnel found that the sheath had allegedly fractured before being used.It was further reported that the guidewire had allegedly become tortuous.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm hemosplit d/l catheter kit was received for evaluation and three photos were provided for review.Visual and microscopic evaluations were performed.The t-handle valve was noted to be damaged.Material deformation to distal tip of the dilator.The photo shows the introducer sheath in which the valve cap was noted to be separated and the sheath was partially peeled.The guidewire was noted to be kinked and twisted in the photos.Therefore, the investigation is confirmed for the reported guidewire twist and the identified deformation due to compressive stress, separation failure and material separation issues.However, the investigation is unconfirmed for the reported fracture issue as no sheath fracture was noted.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.H10: d4 (expiry date: 06/2024).H11: 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 Description

It was reported that prior to a dialysis catheter placement procedure in the right internal jugular vein, the healthcare personnel found that the sheath had allegedly fractured before being used.It was further reported that the guidewire had allegedly become tortuous.The procedure was completed using another device.There was no patient contact.

• Brand Name: HEMOSPLIT CATHETER
• Type of Device: DIALYSIS CATHETER
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17359386
• MDR Text Key: 319372888
• Report Number: 3006260740-2023-03073
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: REHP3673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1