MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when placing the picc the wire went in smoothly, introducer placed w/o incident.When retracting the wire from the introducer it made it most of the way out but was not able to be removed fully.I instructed her to remove both wire and introducer at the same time as we would if it were the needle instead of the introducer.The introducer was removed fully but the wire at just the most distal tip was under the skin and would not budge.I was gowned up at this point and could see the wire in his tissue.When i removed the probe from his arm it must have manipulated the wire just enough that it came out on its own.Neither one of us pulled or tugged trying to extract it.When i examined it the very end of the original wire where the floppy casing is that casing was pulled back from the inner wire.It will re-sheath itself, but it definitely pulls back and exposes a rougher edge.It's like, a mm.
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 difficulty advancing the guidewire through an introducer needle was confirmed.The product returned for evaluation was one nitinol guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The distal, coiled region of the guidewire appeared to have bends along the distal end of the device.The introducer needle was not returned for evaluation.A functional test of attempting to slide the guidewire into the luer of a non-complainant introducer needle revealed the coiled region of the guidewire would not insert into the introducer needle.A functional test of attempting to slide the introducer needle over the proximal end of the guidewire revealed the guidewire would not insert into the introducer needle past the sheath of blood residues along the returned guidewire.A microscopic observation of the distal end of the guidewire showed an uneven and misaligned coil wire from pulling the guidewire back against an introducer needle bevel.Biological material was also seen on the wire which may have contributed to the observed guidewire failure as retraction of the wire together with the biological material could have caused the pieces to become stuck.The characteristics observed on the returned guidewire are indicative of a tensile failure caused by excessive pulling forces on the guidewire.As a note, normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23424494
• Report Number: 3006260740-2025-08189
• Device Sequence Number: 9799042
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510(11)250722(17)260831(10)REKT0249
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1194108D
• Device Lot Number: REKT0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: Other
• Patient Sex: Unknown