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

Catalog Number	3274355
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
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.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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that the picc was placed on (b)(6) 2025; discharged home with picc.On (b)(6) 2025 patient presented to the ed for evaluation of picc.During dressing change at home that morning, the picc was noted to be leaking.The vascular access team was consulted for leaking at the insertion site.Chest x-ray confirmed no change in catheter tip position terminating in the svc.Upon assessment dressing was intact with ¿mushrooming¿ of biopatch indicating leakage at site.Pt denied pain to site.White port was accessed, blood return noted.When flushed normal saline immediately flowed out from insertion site, suspicious for picc fracture.New 4 fr dual lumen picc was placed in the left upper arm, cephalic vein, while patient was in the emergency department.Previous picc was removed.No further information 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 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.The catheter was observed to be kinked between the 0 and 1 cm depth markings.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.
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 information 7/22/25.Patient being treated for hodgkin's lymphoma.Picc was secured with a 4fr securacath.

• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22527106
• Report Number: 3006260740-2025-04902
• Device Sequence Number: 18340064
• Product Code: LJS
• UDI-Device Identifier: 00801741027864
• UDI-Public: (01)00801741027864(11)241230(17)260930(10)REJY1020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 3274355
• Device Lot Number: REJY1020
• 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; 08/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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: Other
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 90 KG