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

Catalog Number	C1295118
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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 the customer that after the placement of the magnetic navigation catheter, there have been frequent cases of catheter scale disappearance during maintenance, and the disinfectants used in clinical practice are iodophor and chlorhexidine disinfectants.The exact number of occurrences was not provided by the complainant.No further information was provided.
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 markings wearing off a picc is confirmed; however, the exact cause is unknown.One photograph of a dual-lumen powerpicc was returned for evaluation.An initial visual observation of the photograph showed the device implanted into the patient with a transparent dressing over the molded joint and tubing.No markings could be seen on the molded joint or tubing.No indication of the root cause for the worn off markings could be discerned from the photograph.No additional damage was noted.Marking wear can potentially occur when using an incompatible chemical with the device; however, the event description indicated that compatible disinfectants (an iodine-based disinfectant and chg) were used.The product ifu states, "chlorhexidine gluconate and/or povidone iodine are the suggested antiseptics to use." this complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24675593
• Report Number: 3006260740-2026-01893
• Device Sequence Number: 16023556
• Product Code: LJS
• UDI-Device Identifier: 00801741218125
• UDI-Public: (01)00801741218125(11)250625(17)270430(10)REKS1987
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K210264
• 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): 05/05/2026

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 Catalogue Number: C1295118
• Device Lot Number: REKS1987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: Other
• Patient Sex: Unknown