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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refu1793 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
The customer reports: ¿at the connection between power trialysis and the machine the hub is unstable (not tight).It twists and this increases the access pressure.¿ additional information 1/18/2022: the power trialysis 5618200 with the lot refu1793 exp.Date 2023/03/31.This product is used for hemofiltration and when the curved line is connected to the machine, the tubing becomes very soft and twists in such a way that the flow is interrupted.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED KIT 13F TL 20CM
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13374077
• Report Number: 3006260740-2022-00104
• Device Sequence Number: 11998196
• Product Code: NIE
• UDI-Device Identifier: 00801741041990
• UDI-Public: (01)00801741041990
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 01/13/2022

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: 5618200
• Device Lot Number: REFU1793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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