MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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.The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that "during a picc placement today, i had an introducer not tear appropriately.Part of the orange handle did not separate, which i think caused the grey part to not tear as well.I know we had this happen one other time within the last few months.No patient harm/injury occurred." this report addresses the event on january 16, 2025.
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 an improper peel of a microintroducer sheath is confirmed; however, the exact cause is unknown.One photograph of a microintroducer was returned for evaluation.An initial visual observation of the photograph showed the microintroducer partially peeled with what appears to be excess material on one side of the split t-handle, suggesting the t-handle did not break correctly.However, details of the fracture surfaces could not be discerned from the returned photograph.Use residue was observed on the sample in the returned photograph.There were no distinguishing features in the returned photograph 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 SOLO2, 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21525801
• Report Number: 3006260740-2025-01208
• Device Sequence Number: 20916540
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510(11)241112(17)260228(10)REJW2592
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/28/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 1194108D
• Device Lot Number: REJW2592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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