MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROV THICK TAPER SOLO2, 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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer reached out that they found something in the picc kit prior to insertion they thought it might be mold or something.This was not used on a patient.No other 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 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 foreign material found inside a picc kit is confirmed, but the root cause could not be determined.One powerpicc provena kit was returned for evaluation.Two photographs of a powerpicc provena kit were returned for evaluation.An initial visual observation showed the kit was returned opened.No obvious use residues were observed inside the kit or the kit contents.Inspection of the returned kit contents revealed multiple small, white and gray substances inside the kit tray resembling dust debris.No specific characteristics of the debris were observed to identify the debris inside the kit tray.An initial visual observation of the photographs showed multiple small objects, resembling dust debris, inside the kit.No use residues were observed on the sample in the returned photograph.No damage could be seen on the sample in the returned photograph.It was observed that the foreign material in the photographs were on the hair covering, while the foreign material found inside the returned kit were observed to be in the kit tray, as the foreign material likely moved during transport of the kit.Because the kit was returned opened, it could not be determined when the foreign material entered the powerpicc provena kit.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROV THICK TAPER 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21329220
• Report Number: 3006260740-2025-00442
• Device Sequence Number: 15433375
• Product Code: LJS
• UDI-Device Identifier: 00801741154911
• UDI-Public: (01)00801741154911(11)240709(17)251031(10)REJS2537
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 05/07/2025

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S1395108D2
• Device Lot Number: REJS2537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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