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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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 report will be submitted with evaluation results.
Event or Problem Description
It was reported that when opening kit to place picc, there was a hair found on top of the enclosed sterile gown.Upon further inspection, there were no other hairs found anywhere within the kit.There was no report of patient harm.
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 foreign material is confirmed; however, the root cause could not be determined.One photograph of a drape or gown was returned for evaluation.The returned photograph showed a hair-like object on a drape/gown.No other details were observed in the photograph.Based on the returned photograph, it could not be determined when or where the foreign object entered the kit.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC FT SOLO2 (SHORT 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22682553
• Report Number: 3006260740-2025-05467
• Device Sequence Number: 8937219
• Product Code: LJS
• UDI-Device Identifier: 00801741155116
• UDI-Public: (01)00801741155116(11)250325(17)260228(10)REKP0157
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: S1295108FD4
• Device Lot Number: REKP0157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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