MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC TL 24CM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
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 refs3124 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported insertion of shaldon femorally, puncture without any problem and advancement of the wire with control of the wire intranasally, dilatation without any problem, wire always freely movable during this time.Now an attempt to selding the catheter over the wire it was not possible, because the wire (part that was in the muscle) has massive bends.It also shows that the wire kinks at the slightest touch.Consequence: in a fully anticoagulated patient, 2nd puncture, same brand but new set - no problems.
Event or Problem Description
It was reported insertion of shaldon femorally, puncture without any problem and advancement of the wire with control of the wire intravasally, dilatation without any problem, wire always freely movable during this time.Now an attempt to selding the catheter over the wire it was not possible, because the wire (part that was in the muscle) has massive bends.It also shows that the wire kinks at the slightest touch.Consequence: in a fully anticoagulated patient, 2nd puncture, same brand but new set - no problems.
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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent guidewire is confirmed; however, the exact cause is unknown.One 0.035 in.¿j¿-tip guidewire in a plastic hoop, one 24 cm trialysis catheter, one 13 fr dualator dilator, and one 14 fr dualator dilator were returned for evaluation.An initial visual observation showed use residue on the returned guidewire.Multiple bends were observed in the returned guidewire with the most severe bends about 14 cm and 19 cm proximal to the distal tip.The core wire was found to be intact during tactile evaluation of the guidewire.A microscopic observation revealed two kinks and one gap in the coiled wire of the returned guidewire.While the exact cause of the damage observed in the returned guidewire is unknown, possible contributing factors include insertion of the guidewire or catheter against resistance, damage during insertion of manipulation of the guidewire, advancement/retraction of the guidewire at a sharp angle, and patient anatomy.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC TL 24CM
• 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: 12960877
• Report Number: 3006260740-2021-05183
• Device Sequence Number: 14804950
• Product Code: NIE
• UDI-Device Identifier: 00801741041914
• UDI-Public: (01)00801741041914
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 5608240
• Device Lot Number: REFS3124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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