MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F 20CM TL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx5423 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refx5423) have been reported from the same facility.
Event or Problem Description
It was reported "the clinicians stated that they cannot feed the wire through the port upon insertion due to fraying of the wire itself." it was reported this occurred with two devices.This report addresses the first device.
Additional 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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to advance the guidewire through the catheter is confirmed and appears to be manufacturing related.One 20 cm trialysis catheter and one guidewire were returned for evaluation.Blood residue and evidence of use was noted on the catheter.The returned guidewire was inserted from the distal end of the power injectable lumen of the catheter.Resistance was noted 1 cm from the distal end of the catheter.The catheter was cut at the region resistance was experience in order to measure the lumen dimensional properties.The lumen size was found to be below manufacturing specification which is a likely factor to the difficult guidewire advancement; therefore, the complaint is confirmed.Bd is working closely with the supplier/manufacturing to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "the clinicians stated that they cannot feed the wire through the port upon insertion due to fraying of the wire itself." it was reported this occurred with two devices.This report addresses the first device.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F 20CM TL
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13806598
• Report Number: 3006260740-2022-00841
• Device Sequence Number: 16661284
• Product Code: NIE
• UDI-Device Identifier: 00801741041860
• UDI-Public: (01)00801741041860
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5603200
• Device Lot Number: REFX5423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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: Other
• Patient Sex: Unknown