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

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	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer "on (b)(6), i received a consult to insert a picc in a critical patient in er.Successful procedure, but when completing my final flushes of the line, i noticed normal saline leaking from the white lumen and blood back flowing.Upon further inspection, i discovered a small crack in the line right at the hub of the picc.I immediately pulled the line and placed a bandage.Patient needed to go to icu urgently so i followed patient there and completed a second successful picc attempt in icu using a different lot number." additional information received (b)(6) 2025: it was reported the customer "patient had an additional peripheral iv but it wasn't great.It was a smaller gauge and leaking.She was also running norepinephrine (which is a potent vasoconstrictor) that needs to be runs centrally ex) via a picc line.No, it did not contribute to the decline in patient condition.The picc line would have helped the staff care for the patient easier but she was already deteriorating and going over to icu.Icu did however require the picc line as by the time she got transferred to icu her iv line had went interstitial and they needed to urgently intubate her, thus requiring iv access.".
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 leak was confirmed and determined to be use related.The product returned for evaluation was one 5fr tl powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument such as a scalpel.The returned product sample was evaluated, and a split was observed at the distal end of the extension tubing on the white lumen.Microscopic examination of the split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: POWERPICC HF SOLO2 (HIGH FLOW), 3CG
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22319166
• Report Number: 3006260740-2025-04214
• Device Sequence Number: 8794449
• Product Code: LJS
• UDI-Device Identifier: 00801741085727
• UDI-Public: (01)00801741085727(11)241007(17)260131(10)REJW2690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• 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): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1395118Q
• Device Lot Number: REJW2690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: Required Intervention
• Patient Sex: Unknown