MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA THICK TAPER; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

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	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the picc rn at the hospital was unable to flush this picc line or thread the guidewire.We took an x-ray and there seemed to be an obstruction.Another picc kit was used.No harm occurred.
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 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 an occlusion in the catheter is confirmed and was determined to be related to the manufacture of the catheter.One 5 fr t/l powerpicc catheter was returned for evaluation.Two photographs were returned for evaluation.An initial visual observation of the first returned photograph showed an x-ray image of only the catheter.It was observed in the x-ray image that a section of the catheter shaft in the tapered region had a solid gray coloring unlike the rest of the catheter shaft in the x-ray image.A tactile evaluation of the returned catheter revealed a hard section of catheter from between the 0 cm and 1 cm depth marking to between the 2 cm and 3 cm depth marking.A functional test of attempting to infuse water into each of the three lumens using a 12 ml syringe revealed the gray and white lumens to be patent to infusion with some observable resistance.It was observed that the red lumen was completely occluded and unable to infuse.The catheter was cut to identify the occlusion in the catheter.A microscopic observation of the inside catheter segment with the occlusion revealed a piece of metal inside the catheter shaft.The metal was removed from the catheter shaft.The metal appeared to be a detached molding pin/rod.One end of the metal section was observed to be rounded.One longitudinal side of the metal pin was observed to be rounded while the other longitudinal side was observed to be flat.The occlusion was removed from the catheter shaft to reveal a piece of molding equipment inside the device.This failure was determined to be caused during the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA THICK TAPER
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21363648
• Report Number: 3006260740-2025-00583
• Device Sequence Number: 15594377
• Product Code: LJS
• UDI-Device Identifier: 00801741219849
• UDI-Public: (01)00801741219849(11)240904(17)251130(10)REJT1284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CK001006
• Device Lot Number: REJT1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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