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

Catalog Number UNK DIALYSIS

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that during a dialysis catheter placement, the tunneler allegedly detached.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

It was reported that during a dialysis catheter placement, the tunneler allegedly detached.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 19cm pristine d/l catheter was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported detachment issue and the identified fracture, material protrusion and deformation issues, as a tunneler protective sheath was loaded on the distal end of the catheter.The protective sheath appeared to have bunching throughout.The distal tip of the protective sheath appeared to be fractured.The edges of the fracture appeared jagged.A definitive root cause could not be determined based upon the available 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.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 Description

It was reported that during a dialysis catheter placement, the tunneler allegedly detached.The procedure was completed using same device.There was no reported patient injury.

Event Description

It was reported that during a dialysis catheter placement, the tunneler allegedly detached.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 19cm pristine d/l catheter was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported detachment issue and the identified fracture, material protrusion and deformation issues, as a tunneler protective sheath was loaded on the distal end of the catheter.The protective sheath appeared to have bunching throughout.The distal tip of the protective sheath appeared to be fractured.The edges of the fracture appeared jagged.Furthermore, the loaded protective sheath was removed from the distal end of the catheter.Under microscopic observation, the distal end of the catheter was noted to be blunt with residue throughout.The distal tip of the protective sheath appeared to be fractured.The edges of the fracture appeared jagged.Deformation was noted throughout the protective sheath.A definitive root cause could not be determined based upon the available 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.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.

• Brand Name: PRISTINE
• 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: 13576916
• MDR Text Key: 285936918
• Report Number: 3006260740-2022-00416
• Device Sequence Number: 1
• Product Code: MSD
• 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,Followup
• Report Date: 09/14/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK DIALYSIS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 09/14/2022
• Supplement Dates FDA Received: 04/28/2022; 09/22/2022
• 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