MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC HF SOLO2 (HIGH FLOW), 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER

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	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that picc is breaking and noticing leaking at the insertion.No impact known to the patient at this time.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 leaking in the catheters is confirmed and was determined to be use-related.Two 5 fr t/l powerpicc solo catheters were returned for evaluation.An initial visual observation of the returned catheters showed blood residues throughout the devices.Sample 1 was returned with a broken secur-a-cath device.Compression damage was observed along sample 1 just distal of the molded suture wings to the 3 cm depth marker.A longitudinal split was observed along sample 1 just distal of the 0 cm depth marker.Compression damage was observed along sample 2 just proximal of the 1 cm depth marker to the 3 cm depth marker.A circumferential kink was observed along sample 2 just distal to the molded suture wings.A longitudinal split was observed just distal to the molded suture wings at the circumferential split site along sample 2.A microscopic observation revealed each of the splits to have a granular fracture surface and sharp fracture edges.The splits for each of the returned devices were observed to extend in length more on the outside surface of the catheter than on the inside surface of the catheter.The splits were observed to be in the same location as the compression damage.Use of compression stylet securement devices is likely to have contributed to the failure of the device.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC HF SOLO2 (HIGH FLOW), 3CG
• 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: 22396259
• Report Number: 3006260740-2025-04515
• Device Sequence Number: 4799680
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725(11)250319(17)260531(10)REKN3777
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/28/2025

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1395108QD
• Device Lot Number: REKN3777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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