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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
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 device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported patient arrived to unit from ed.On admission, the bedside nurse noticed the burn netting over the patients picc line was saturated with blood.Upon inspection of picc dressing, the edges were nonocclusive and the entire dressing was saturated with blood.Per report from ed rn dressing had small amount of blood, but per charting multiple staff noted dressing was soiled and need to be changed.I also noticed both the distal and proximal lumen had blood in the tubing.The proximal lumen still had home iv infusion line attached.When asked, mother stated the dressing has looked that way since arriving to ed (6/29/1529).Photos were taken upon admission and uploaded to the chart.Md notified of picc line status, and for plan clarification.Per md, was instructed to complete a dressing change, and to access and hep lock the distal lumen if not occluded by thrombus that was noted on ultrasound in ed.Dressing was changed, distal lumen flushed, and dressing was immediately saturated by blood and saline from flush.Distal lumen leaking towards insertion site and leaking towards the middle of the tubing.Unable to hep lock due to med leaking out of the line.Md notified, was instructed to complete a dressing change, and picc team will evaluate in am.Mom refused second dressing change, due to concern for infection and line not functional due to leaking.As well as subjecting patient to another sterile dressing change.
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
Additional event details: readmission through ed on (b)(6)2025, sent from home health due to picc not functioning properly for 1 day.Home health nurse attempted flushing line prior to treatment with antibiotics and was unable to flush, with bleeding beneath the dressing.Chest x-ray showed the catheter tip position at the cavoatrial junction.Vascular access team called to assess the patient's picc due to report of a leaking (spraying) from the picc with each flush, bleeding from the picc site, an occluded white lumen and blood backed up into the red lumen.When the dressing was taken down, leaking was noted from under the biopatch, the catheter appeared to be kinked and there was leaking at the picc side of the flange/hub and leaking from the white lumen at the edge of the flange/hub on the other side.The picc was removed.And peripheral iv placed.Patient had an occlusive thrombus of the right cephalic vein.Picc had been secured with a 4fr securacath patient was being treated for bacteremia, septic thrombophlebitis, and suspected endocarditis.
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 leaking catheter is confirmed and was determined to be use-related.One 4 fr dual lumen powerpicc sv catheter was returned for evaluation.An initial visual observation revealed use residue on the sample.A kink was observed between the molded joint and the 0cm depth marking.Both lumens of the sample were flushed with a 12 ml syringe of water.A leak was observed just distal to the molded joint from both red and white lumens.A microscopic observation revealed a split where the leak was seen.The split was observed to have uneven edges, wrinkling near the edges, and a rough fracture surface.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue may occur due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack in the catheter.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV (SMALL VEINS)
• 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: 22527301
• Report Number: 3006260740-2025-04905
• Device Sequence Number: 18457661
• Product Code: LJS
• UDI-Device Identifier: 00801741027864
• UDI-Public: (01)00801741027864(11)240212(17)270331(10)REHZ1888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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 Model Number: N/A
• Device Catalogue Number: 3274355
• Device Lot Number: REHZ1888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025; Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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; Other
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 21 KG