MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer, "during placement of a picc i noticed that when i aspirated to check for blood return that air was coming into my syringe.I removed the syringe from the injection port and expelled the air then reattached and flushed the line.I noticed that the saline was leaking out from around the wire coming out of the rubber (unsure of material here) stopper.After ensuring that all my connections were tightly secured, i attempted to aspirate again and pulled air into my syringe.I removed the syringe, expelled the air, reattached and attempted to flush a second time noting fluid again leaking from the same area when flushing.Syringe removed and placed on the other lumen (purple) and was able to aspirate blood and flush without issue.I was able to look closer and noticed the leaking.Patient was sent home with the picc the next day for 8 weeks of iv antibiotics.The event was not urgent or life threatening.There was no harm to the patient.Patient has no recorded infectious diseases.".

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17060941
• Report Number: 3006260740-2023-02260
• Device Sequence Number: 20976799
• Product Code: LJS
• UDI-Device Identifier: 00801741154942
• UDI-Public: (01)00801741154942
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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
• Report Date (Section B): 06/02/2023

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D3
• Device Lot Number: REGZ0208
• 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: 03/22/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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 Age: 65 YR
• Patient Sex: Female