MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA THICK TAPER, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported picc was placed (b)(6) 2024 and discontinued (b)(6) 2025 after patient complained of moderate pain during flushing and infusions.Also complained of leaking of fluids at insertion site.When removed, the line was found to have 1 break in the picc line.This break was vertical and was at/near the 6cm mark.Temporary pain and mild swelling to upper arm in regards to ivf infiltration.No permanent damage discovered.
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 a leaking catheter is confirmed and was determined to be use-related.One 5 fr t/l powerpicc catheter was returned for evaluation.An initial visual observation of the returned catheter showed blood use residues throughout the returned device.Inspection of the returned catheter showed a longitudinal split between the 5 cm and 6 cm depth marking.A microscopic observation of the split in the returned catheter revealed the split to have a granular fracture surface with sharp fracture edges.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.It was likely that the observed damage was related to catheter over-pressurization (burst) damage.This can occur due to flushing with a syringe smaller than 10ml, power injecting through the affected lumen (which is not power injection rated), or by forceful flushing against an occlusion.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA THICK TAPER, 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21329046
• Report Number: 3006260740-2025-00429
• Device Sequence Number: 12912448
• Product Code: LJS
• UDI-Device Identifier: 00801741154966
• UDI-Public: (01)00801741154966(11)240611(17)250930(10)REJR2608
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S1385108D3
• Device Lot Number: REJR2608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Other
• Patient Sex: Unknown