MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that while flushing picc the rubber stopper popped out.Defective and not able to be pushed back into space where rubber stopper was.Picc successfully placed.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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2024-01250.
Event or Problem Description
It was reported by customer that while flushing picc the rubber stopper popped out.Defective and not able to be pushed back into space where rubber stopper was.Picc successfully placed.No other information was provided.

• Brand Name: POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 20835370
• Report Number: 3006260740-2024-07160
• Device Sequence Number: 8738734
• Product Code: LJS
• UDI-Device Identifier: 00801741155161
• UDI-Public: (01)00801741155161(11)240701(17)250630(10)REJS0189
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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): 12/11/2024

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S1275108FD5
• Device Lot Number: REJS0189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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