MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 HemoSplit Long-Term Hemodialysis Catheter, Polyurethane, 14.5F

Catalog Number	5733270
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dysphasia (2195); Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that the patient underwent placement of a hemosplit hemodialysis catheter on (b)(6)2026, at (b)(6).Following insertion, it was determined that the right sided dialysis catheter had been inadvertently inserted through both walls of the internal jugular vein into the mediastinum.The patient was transferred to (b)(6) ) for further management and catheter removal.On (b)(6) 2026, the patient was admitted to the cardiothoracic critical care unit (ctccu).The misplaced catheter was removed in a hybrid theatre/angiography suite using guidewire-assisted removal with balloon tamponade.The removal procedure was uneventful, and a new left-sided dialysis catheter was subsequently inserted.Following intubation for the catheter removal procedure, the patient developed type ii respiratory failure and required prolonged mechanical ventilation in ctccu.After extubation, the patient experienced new-onset expressive dysphasia and left upper limb weakness, requiring re-intubation.A ct scan performed on (b)(6) 2026, demonstrated pre-existing cerebral infarcts and no evidence of intracranial hemorrhage.The patient was transferred back to (b)(6) on (b)(6) 2026 and remained ventilated.The current status of the patient is unknown.
Event or Problem Description
It has been reported that the patient underwent placement of a hemosplit hemodialysis catheter on (b)(6) 2026, at salford royal.Following insertion, it was determined that the right sided dialysis catheter had been inadvertently inserted through both walls of the internal jugular vein into the mediastinum.The patient was transferred to (b)(6) nhs foundation trust (wythenshawe) for further management and catheter removal.On (b)(6) 2026, the patient was admitted to the cardiothoracic critical care unit (ctccu).The misplaced catheter was removed in a hybrid theatre/angiography suite using guidewire assisted removal with balloon tamponade.The removal procedure was uneventful, and a new left sided dialysis catheter was subsequently inserted.Following intubation for the catheter removal procedure, the patient developed type ii respiratory failure and required prolonged mechanical ventilation in ctccu.After extubating, the patient experienced new onset expressive dysphasia and left upper limb weakness, requiring re intubation.A ct scan performed on (b)(6) 2026, demonstrated preexisting cerebral infarcts and no evidence of intracranial hemorrhage.The patient was transferred back to salford icu on (b)(6) 2026 and remained ventilated.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.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 requested as the lot number reported is unknown.Investigation summary: one 27cm hemosplit d/l catheter was returned for sample evaluation.Gross visual, microscopic, tactile and functional evaluations were performed on the returned device.The complaint sample appeared to have residue.The catheter felt normally elastic when it was gently pulled and stretched.The reported information states that following insertion, the right sided dialysis catheter had been inadvertently inserted through both walls of the internal jugular vein into the mediastinum.Therefore, the investigation is confirmed for the reported improper procedure or method issue as the catheter inserted into the mediastinum.The root cause of the reported issue is related to user error.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instruction for use states that caution: placement and care of hemodialysis catheters should be performed by persons knowledgeable of the risks involved and qualified in the procedures.Insertion technique (1) percutaneous placement procedure of the hemosplit or hemosplit xk catheter with cuff using the bard access systems, inc.Split sheath introducer: for percutaneous placement, the catheter is inserted in either the subclavian vein or internal jugular vein through a split sheath introducer.It has been reported that right side, internal jugular placement is the preferred initial location of consideration for percutaneous insertion.The patient should be placed in trendelenburg position with the head turned to the opposite side of the entry site.D4 (medical device catalog#), g3, h6 (patient, 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.

• Brand Name: HemoSplit Long-Term Hemodialysis Catheter, Polyurethane, 14.5F
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50137649
• Report Number: 3006260740-2026-05291
• Device Sequence Number: 21452152
• Product Code: MSD
• UDI-Device Identifier: 00801741013010
• UDI-Public: (01)00801741013010
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: UK
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5733270
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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 Sex: Unknown