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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fungal Infection (2419); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "cns at bedside with rn to do dressing change.When nurse went to turn patient, she lifted patient's left arm and noted discoloration and edema below the patient's picc, no other lines present.Provider was called to bedside.All infusions were stopped, clamped.Plastics consult placed stat.Consulting surgeon came to bedside.Advised rn not to apply any compress or administer any antidote, due to multiple infusions and discoloration already appearing.Service will follow patient to assess for any wound evolvement.Suspecting picc product failure, due to picc placement confirmed on morning chest x-ray." additional information provided: patient impact: temporary physical harm, as well as an extra xray to determine the picc had failed.Patient presented oddly with what appeared to be an extravasation.After further diagnostic workup, a dvt was discovered, along with an angio-invasive fungal infection of the soft tissue.We now do not believe there was an extravasation present.Medication used to treat edema includes multiple medications including vasoactives, tpn, and antibiotics.Catheter was not replaced.Patient is not to have any iv placed in the lue that now requires twice per day wet to dry dressing changes.No other information was provided.
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.
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 deep vein thrombosis caused by picc failure is inconclusive because no catheter failure was observed during investigation of the returned device.One 5 fr t/l powerpicc catheter was returned for evaluation.An initial visual observation of the returned device revealed blood use residues throughout the device.No significant discoloration was observed throughout the catheter.A functional test of pressurizing the catheter with water through each lumen using a 12 ml syringe revealed no leaks throughout the catheter.A microscopic observation revealed nothing remarkable throughout the catheter body.No evidence was observed along the returned catheter to be related to the alleged deep vein thrombosis of the patient.Patient clinical conditions such as deep vein thrombosis cannot be conclusively linked to the use of catheter products; therefore, the complaint of dvt is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC HF (HIGH FLOW)
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21365874
• Report Number: 3006260740-2025-00608
• Device Sequence Number: 18246818
• Product Code: LJS
• UDI-Device Identifier: 00801741028205
• UDI-Public: (01)00801741028205(11)240719(17)260430(10)REJS3737
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 3385355Q
• Device Lot Number: REJS3737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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