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

Catalog Number	5733690
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the guidewire tip was allegedly kinked.There was no reported patient injury.
Additional 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2025).H11: section a through f ¿ the information provided 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
It was reported that during a dialysis catheter placement procedure, the guidewire tip was allegedly kinking.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 19cm hemosplit d/l catheter with a loaded tunneler and protective sheath, two luer caps, one introducer needle, one tunneler with a loaded protective sheath, one partially peeled 15.0fr peel-apart sheath, one 8fr dilator, one 12fr dilator, one guidewire hoop and one j-tip guidewire were returned for evaluation.Gross visual and dimensional evaluations were performed.The proximal and distal portion of the j-tip guidewire were noted to be bent.Therefore, investigation is confirmed for the reported deformation issue.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3.H11: d4 (unique identifier (udi) #), h6 (result, conclusion).H11: section a through f: the information provided 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: HEMOSPLIT CATHETER
• Common Device Name: 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: 20436162
• Report Number: 3006260740-2024-05901
• Device Sequence Number: 8440687
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096(17)251130(10)REJN1760
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 5733690
• Device Lot Number: REJN1760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/13/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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