MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERTRIALYSIS; ACUTE DIALYSIS CATHETER

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported foreign body clearly visible before use in the sealed packaging.
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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 foreign material is confirmed and was determined to be manufacturing related.One powertrialysis catheter kit was returned for evaluation.An initial visual observation revealed the package was unopened.A small brown material was observed to be sealed within the ifu packaging.The package was opened for inspection and a microscopic observation revealed the material was fibrous and similar to a cardboard material.These findings indicate the foreign material within the package was caused during the manufacturing process where the components are placed inside the packaging and sealed.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERTRIALYSIS
• Common Device Name: ACUTE DIALYSIS CATHETER
• 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: 21753399
• Report Number: 3006260740-2025-01940
• Device Sequence Number: 9647927
• Product Code: NIE
• UDI-Device Identifier: 00801741041914
• UDI-Public: (01)00801741041914(11)240516(17)260228(10)REJR2887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/16/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 5608240
• Device Lot Number: REJR2887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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