MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2; 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	12/09/2025
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported placed a powerpicc solo on (b)(6) and it flushed fine.On (b)(6) the line felt occluded, they administered tpa and it still was occluded, they then noticed a piece of catheter material in the lumen of the picc line.They took the line out of the patient and cut the lumen to examine the piece of purple catheter stuck in it.Patient needed new line placed and delay in care due to not being able to use this line.
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 material found inside the device is confirmed, but the root cause could not be determined.One powerpicc solo catheter was returned for evaluation.Two photographs of a powerpicc solo catheter were returned for evaluation.An initial visual observation of the returned catheter showed use residues along the device.The catheter was returned cut into four pieces; the first cut was along the extension tubing just proximal to the molded joint, the second cut at the 1 cm depth marker, and the third cut was observed between the 14 cm and 15 cm depth markers.An initial visual observation of the two returned photographs showed the extension tubing of the powerpicc solo with a small, dark object inside the extension tubing.The second returned photograph showed a small, purple object on a white surface alongside the trimmed catheter.The purple object appeared to be the same color purple as the molded joint in the returned photograph.This small purple object was not returned for evaluation, and it was not initially observed inside the catheter shaft upon initial visual observations.A functional test of attempting to infuse water into the solo valve using a 12 ml syringe revealed no occlusion of the device, and no foreign material was seen exiting any section of the device.A functional test of attempting to infuse water into each section of catheter using a 12 ml syringe and a 4 fr groshong proximal connector revealed each section to be patent to infusion.The complaint of foreign material inside the device is confirmed through the returned photographs; however, because no foreign material was found during inspection of the returned physical sample, the root cause of the failure and identification of the foreign material could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2
• 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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23851489
• Report Number: 3006260740-2025-09890
• Device Sequence Number: 9571824
• Product Code: LJS
• UDI-Device Identifier: 00801741212789
• UDI-Public: (01)00801741212789(11)250908(17)260731(10)REKT1553
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CK000586B
• Device Lot Number: REKT1553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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