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

Catalog Number	CK000403
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 picc kit was returned as a random staple was found in kit and kit was contaminated.Staple found in kit prior to insertion.No report of patient harm or injury.
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 in the packaging is inconclusive due to the state of the returned sample.The product returned for evaluation was one 5fr dl powerpicc solo catheter kit.A gross visual inspection of the returned kit found that the csr wrap was loosely wrapped around the kit.The csr wrap was unfolded and a staple was found atop the gown.The rest of the kit was inspected, but no other foreign material was identified.The opened state of the sample made it difficult to assess when and where the staple was introduced into the kit.The complaint of foreign material in the packaging could not be independently confirmed without evaluation of a sealed kit; however, the report event has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• Brand Name: POWERPICC, 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21370687
• Report Number: 3006260740-2025-00622
• Device Sequence Number: 8564482
• Product Code: LJS
• UDI-Device Identifier: 00801741096228
• UDI-Public: (01)00801741096228(11)241010(17)251031(10)REJV0905
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 05/14/2025

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 Catalogue Number: CK000403
• Device Lot Number: REJV0905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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