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

Catalog Number	5834190
Medical Device Problem Codes	Collapse (1099); Restricted Flow rate (1248); Difficult to Flush (1251); Stretched (1601); Suction Problem (2170); Material Protrusion/Extrusion (2979); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 approximately one year, eight months, and nine days post a dialysis catheter placement, the arterial lumen of the catheter was allegedly collapsed severely on aspiration and allegedly distended on flushing the arterial line.There was no reported patient injury.
Event or Problem Description
It was reported that sometime post a dialysis catheter placement, the arterial lumen of the catheter was allegedly collapsed severely on aspiration and allegedly distended on flushing the arterial line.It was further reported that the portion of the catheter was allegedly very soft and pliable and the clearance was allegedly low even if there was no recirculation.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one 24cm hemostar d/l catheter was received for evaluation.Visual, tactile and functional testing were performed.The red luer extension leg was noted to have ballooning as it felt soft upon stretching.Both red and blue luer and was patent to infusion and aspiration.No leaks were observed throughout the catheter.The red luer extension leg was observed to slightly expand at the ballooning portion.Therefore, the investigation is confirmed for the reported material protrusion, stretched and material soft issues.However, the investigation is inconclusive for the reported restricted flow rate, suction issue and flush issue as no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.The investigation is also inconclusive for the reported collapse issue as the exact circumstances at the time of reported event is unknown.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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: HEMOSTAR
• 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: 19622925
• Report Number: 3006260740-2024-03298
• Device Sequence Number: 6434147
• Product Code: MSD
• UDI-Device Identifier: 00801741013430
• UDI-Public: (01)00801741013430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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 Catalogue Number: 5834190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/22/2024
• 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