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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported picc line was placed successfully.Line started to show signs of complication and during a unrelated chest xray they realize the line had broken around 4 cm from the tip of the catheter.Line was removed by cath lab in two segments.Additional information: on (b)(6) 2025, it was discovered that a patient's double lumen picc had broken inside the patient about 5 cm above the tip.The picc was inserted on (b)(6) 2025 by a psvmc iv therapy rn at bedside via 3cg in the icu.On (b)(6) 2025, a routine chest xray discovered the broken line.The line had become symptomatic as the nursing team was having difficulty getting blood return.Dr.With ir performed the procedure on (b)(6) 2025.Iv rn was at the bedside during the procedure to replace the picc line.A new picc line was successfully placed.No detectable harm to the patient, aside from the cath lab procedure required to correct the issue.Femoral access was required to remove the broken end of the line.
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.
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 broken catheter is confirmed; however, the exact cause is unknown.Eight photographs of a powerpicc were returned for evaluation.An initial visual observation of the photographs showed a break near the distal end of the catheter.The fracture was observed to be at the 35 cm mark.The distal fragment was observed to be approximately 5 cm.No details of the fracture surface could be discerned from the returned photographs.Use residue was observed on the sample.No additional damage to the catheter was observed in the returned photograph.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA
• 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: 22359286
• Report Number: 3006260740-2025-04395
• Device Sequence Number: 8081498
• Product Code: LJS
• UDI-Device Identifier: 00801741155109
• UDI-Public: (01)00801741155109(11)250325(17)260228(10)REKN3764
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 07/29/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: S1294108D4
• Device Lot Number: REKN3764
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: Required Intervention
• Patient Sex: Unknown