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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "ruptured catheter at the junction of the transparent part of the catheter and the dividing part.Small bubbles found in dialysis set during the treatment, ruptured catheter identified.The catheter was inserted into the patient's femoral vein on (b)(6) 2024.Ruptured catheter identified on (b)(6) 2024.The incident occurred 9.5 hours after the start of the treatment.The treatment was immediately discontinued, catheter was taken out and antibiotics were given to the patient.Patient recovered.".
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "ruptured catheter at the junction of the transparent part of the catheter and the dividing part.Small bubbles found in dialysis set during the treatment, ruptured catheter identified.The catheter was inserted into the patient's femoral vein on (b)(6) 2024.Ruptured catheter identified on (b)(6) 2024.The incident occurred 9.5 hours after the start of the treatment.The treatment was immediately discontinued, catheter was taken out and antibiotics were given to the patient.Patient recovered.".
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 a leaking powertrialysis catheter is confirmed but the exact cause could not be determined.One 15 cm powertrialysis catheter was returned for evaluation.An initial visual observation showed blood use residues throughout the returned catheter.A needleless injection cap was returned attached to the purple lumen of the device.The returned printed photo showed blood leaking through the catheter just distal of the molded joint.A microscopic observation revealed a small split just distal of the molded joint.The split was observed to have a granular fracture surface with whitening around the edges of the circumferentially aligned split.Flexural fatigue, or cyclic kinking of the catheter, may have contributed to the failure; however, after a microscopic observation the cause of the split in the catheter is unknown.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18713229
• Report Number: 3006260740-2024-00547
• Device Sequence Number: 8040309
• Product Code: NIE
• UDI-Device Identifier: 00801741041891
• UDI-Public: (01)00801741041891
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 5608150
• Device Lot Number: REGQ3876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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