MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PRISTINE LONG-TERM HEMODIALYSIS CATHETER

Model Number 5403190

Device Problems Difficult to Flush (1251); Suction Problem (2170); Obstruction of Flow (2423)

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

Event Date 03/29/2023

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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2024).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 Description

It was reported that six days post dialysis catheter placement, the catheter allegedly clotted.It was further reported that the catheter was removed and replaced.There was no reported patient injury.

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 pristine d/l catheter was returned for evaluation.In addition to the returned physical sample, two electronic photos were provided for review.Functional, tactile, gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for the reported catheter clotted issue, suction problem and difficult to flush, as the exact circumstances at the time of the reported event was unknown and the issue cannot be reproduced in the lab.A definitive root cause could not be determined based upon the provided information.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.H10: b5, d4 (expiration date: 04/2024), 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 Description

It was reported that six days post dialysis catheter placement, the catheter allegedly clotted.It was further reported that the catheter did not work.Reportedly, the catheter was removed and replaced.There was no reported patient injury.

• Brand Name: PRISTINE LONG-TERM HEMODIALYSIS 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: 16826704
• MDR Text Key: 314125961
• Report Number: 3006260740-2023-01577
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741219030
• UDI-Public: (01)00801741219030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5403190
• Device Catalogue Number: 5403190
• Device Lot Number: REGT4594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: Black Or African American