MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that introducer failure additional information received 11/22/2024: it was reported the introducer was placed over the guidewire and the vascular access nurse attempted to advance the introducer into the vessel but was unable.A small incision using a scalpel was made next to the guidewire to increase the opening through the skin and, again, the introducer access was attempted but failed.The assisting rn then applied proper sterile garments and attempted to advance the introducer but was unable.A 2nd picc kit was opened and the introducer retrieved.This new introducer was placed over the guide wire and was able to be advanced into the vessel without concern.The procedure was completed without any further delays.Upon examination, it appears that the faulty introducer has an enlarged "ring" area that encircles the component.The "ring" increased the size of the introducer enough that it caught on the vessel wall which was why it was unable to be advanced.There were no complications with exception of the extra incision and time the patient spent with their arm at an uncomfortable position.No additional negative outcomes noted.
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 it 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 damaged microintroducer is confirmed and was determined to be use-related.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation revealed that the sample was returned in two pieces with the distal tip of the sheath appearing to have been cut off.Buckling was observed about 1 or 2 cm proximal to the tip of the sheath.A microscopic observation revealed the tip of the microintroducer sheath was plastically deformed and with some evidence of buckling, which suggests the sheath encountered resistance during the initial insertion.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20924919
• Report Number: 3006260740-2024-07445
• Device Sequence Number: 5107741
• Product Code: LJS
• UDI-Device Identifier: 00801741154874
• UDI-Public: (01)00801741154874(11)240923(17)260131(10)REJV3908
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: S1193108D2
• Device Lot Number: REJV3908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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