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

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer "on april 6, the colleague will insert a bard brand dialysis catheter, power-trialysis 30 cm.The guide is inserted into the femoral vein.Then the usual dilatation with the accompanying dilators.It is not possible to insert the dialysis catheter on the guide.The distal end of the guide is very soft, but we snap it off with a sterile cutter and then the dialysis catheter can be threaded over the guide with resistance.The catheter is very slow to pass over the guide.The guide cannot then be backed out of the dialysis catheter but only gives a failing response, such as the guide being stretched.The guide and catheter are then pulled out as one unit.The procedure had to be stopped.".Additional information received 17-apr-2023: it was reported by bd rep, "there was no patient harm.".
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 complaint of difficult catheter advancement over the guidewire was confirmed.The sample was evaluated and this event was determined to be related to a manufacture condition.Bd is working to prevent future occurrences of similar events and values your support and partnership in communicating this event and coordinating the return of the sample.
Event or Problem Description
It was reported by the customer "on april 6, the colleague will insert a bard brand dialysis catheter, power-trialysis 30 cm.The guide is inserted into the femoral vein.Then the usual dilatation with the accompanying dilators.It is not possible to insert the dialysis catheter on the guide.The distal end of the guide is very soft, but we snap it off with a sterile cutter and then the dialysis catheter can be threaded over the guide with resistance.The catheter is very slow to pass over the guide.The guide cannot then be backed out of the dialysis catheter but only gives a failing response, such as the guide being stretched.The guide and catheter are then pulled out as one unit.The procedure had to be stopped." additional information received 17-apr-2023: it was reported by bd rep, "there was no patient harm.".

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER
• 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 bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16857567
• Report Number: 3006260740-2023-01676
• Device Sequence Number: 8528452
• Product Code: NIE
• UDI-Device Identifier: 00801741041921
• UDI-Public: (01)00801741041921
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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 Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 5608300
• Device Lot Number: REGP3964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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