MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number N/A

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx1482 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported that when the dilator was inserted after inserting the guidewire, feel was very heavy.Therefore, when the tip of the dilator was checked, it was damaged.In addition, the guidewire was bent in the middle.There was no reported patient injury.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of 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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of deformation at the distal tip of the dilator was confirmed and the damage appeared to be associated with use of the device.One guidewire, one 13fr dualator dual diameter vessel dilator, and one 14fr dualator dual diameter vessel dilator were returned for investigation.The guidewire was bent 24 cm and 30 cm from the j-tip.The distal tip of each dilator exhibited plastic deformation.The material flared outward from the tip of the dilator.What appeared to be blood residue was observed within the distal tip of each dilator.The outside diameter of the guidewire was within specification.The observed deformation at the tip of each dilator is consistent with wear against a guidewire.The kink and bending of the wires indicates complications during the procedure.Due to evidence of use and deformation that is consistent with wear against a guidewire, it was determined that the dilators were damaged during use.A lot history review (lhr) of recx1482 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recx1482) have been reported from the same facility in japan.H3 : evaluation findings are in section h.11.

Event Description

It was reported that when the dilator was inserted after inserting the guidewire, feel was very heavy.Therefore, when the tip of the dilator was checked, it was damaged.In addition, the guidewire was bent in the middle.There was no reported patient injury.4/8/2021- two devices were returned.This report addresses the first device.

• Brand Name: POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11174509
• MDR Text Key: 228203380
• Report Number: 3006260740-2020-21333
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K141531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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 Model Number: N/A
• Device Catalogue Number: 5603300J
• Device Lot Number: RECX1482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other