MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EQUISTREAM ALPHACURVE DL CATHETER 14.5FR, 28CM; DIALYSIS CATHETER

Catalog Number	5905280
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	11/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 or Problem Description
It was reported that while the patient's caregiver was changing the dressing around the dialysis catheter, the tubing was inadvertently cut beneath one of the ports.It was further reported that the patient began bleeding out through the cut catheter end and collapsed.Reportedly, the caregiver called 911 and the patient was transported to the emergency room.The bleeding could not be stopped until the tube was clamped in the emergency room.Despite all efforts including transfusion, the patient could not be resuscitated.The patient expired due to exsanguination.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: b2 (date of death).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 or Problem Description
It was reported that while the patient's caregiver was changing the dressing around the dialysis catheter, the tubing was inadvertently cut beneath one of the ports.It was further reported that the patient began bleeding out through the cut catheter end and collapsed.Reportedly, the caregiver called 911 and the patient was transported to the emergency room.The bleeding could not be stopped until the tube was clamped in the emergency room.Despite all efforts including transfusion, the patient could not be resuscitated.The patient expired due to exsanguination.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos or medical records were provided for review.Therefore, the investigation is inconclusive for the reported cut, fluid leak, and patient death, as no objective evidence was provided for review.From the report, the event is stated to be due to inadvertent cutting of the catheter.Therefore, it appears the most likely root cause for the reported material cut, leakage, and patient death is sharp instrument damage due to user error.It is unknown whether patient or product issues contributed to the reported event.At this time, a relationship between the catheter and the reported material cut and death cannot be confirmed.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.D4 (unique identifier (udi) #), d5, e3, g3, h4, h6 (device, component, method).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 while the patient's caregiver was changing the dressing around the dialysis catheter, the tubing was inadvertently cut beneath one of the ports.It was further reported that the patient began bleeding out through the cut catheter end and collapsed.Reportedly, the caregiver called 911 and the patient was transported to the emergency room.The bleeding could not be stopped until the tube was clamped in the emergency room.Despite all efforts including transfusion, the patient could not be resuscitated.The patient expired due to exsanguination.

• Brand Name: EQUISTREAM ALPHACURVE DL CATHETER 14.5FR, 28CM
• 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: 21382410
• Report Number: 3006260740-2025-00652
• Device Sequence Number: 18274119
• Product Code: MSD
• UDI-Device Identifier: 00801741013812
• UDI-Public: (01)00801741013812(11)200617(17)211231(10)REES2407
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5905280
• Device Lot Number: REES2407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 07/16/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 02/20/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2020
• 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: Death
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White