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

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 complaint of an occluded lumen was confirmed and determined to be manufacturing related.The product returned for evaluation was one 5fr tl powerpicc solo catheter w/ t-lock assembly and 3cg stylet.An initial macroscopic and microscopic inspection of the returned sample was unremarkable.The sample was functionally tested by attempting to flush each lumen with water using a luer lock syringe.During testing, the white lumen was found to be occluded, preventing any liquid from passing past the extension tubing.All other lumens flushed without issue.After functional testing, the catheter tubing was stripped at the nose of the molded joint.Upon removal of the catheter tubing, a metallic cylinder was found lodged inside the molded joint of the white lumen.The catheter was cut halfway up the molded joint and the metallic object was found to still be present.At this location, it was clear that the object fully occluded the lumen.The length and metallic nature of the object suggested that it was some type of wire or pin.The object was attempted to be removed from the lumen using pliers, but the object could not be removed as it was firmly lodged inside the lumen.The location and features of the metallic object suggested that the object was introduced during device manufacture.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that e opened up a triple lumen picc and when priming one of the lumens, we were unable to flush it.It was a hard stop when trying to prime the line, the lumen was not clamped.We, in turn, had to open a new kit.

• Brand Name: POWERPICC PROVENA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23919312
• Report Number: 3006260740-2025-10083
• Device Sequence Number: 15710857
• Product Code: LJS
• UDI-Device Identifier: 00801741155079
• UDI-Public: (01)00801741155079(11)250722(17)260630(10)REKT0264
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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
• Report Date (Section B): 12/20/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: S1385108D4
• Device Lot Number: REKT0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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