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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that hub just popped off.Additional info received on 14 august 2023: patient admitted to facility (b)(6) 2023.Ra was part of the transition of patients moving from the old icu to the new pavilion icu when the nurse noticed that the white hub on the picc line was laying in the bed.The nurse stated that there was no tugging or pulling on the lines during the move and that no infusions were running at the time.The picc catheter and dressing was intact, only the white hub was detached from the hub line of the picc.Product was intact and dwelling in ra's right arm since placement on(b)(6) 2023.It appears that it is a hub detachment.The event directly involved the patient.The picc catheter had to be replaced.The event involved an urgent replacement of the picc catheter d/t drug infusions needing to be restarted.No patient harm or complication came from the event, an event report was written up and a new picc line had to be placed.No negative impact occurred to the patient.After transition to the new pavilion icu, a new picc line was established, and the patient received her infusion.
Event or Problem Description
It was reported by customer that hub just popped off.Additional info received on v14 august 2023: patient admitted to facility on (b)(6) 2023.Ra was part of the transition of patients moving from the old icu to the new pavilion icu when the nurse noticed that the white hub on the picc line was laying in the bed.The nurse stated that there was no tugging or pulling on the lines during the move and that no infusions were running at the time.The picc catheter and dressing was intact, only the white hub was detached from the hub line of the picc.Product was intact and dwelling in ra's right arm since placement on (b)(6) 2023.It appears that it is a hub detachment.The event directly involved the patient.The picc catheter had to be replaced.The event involved an urgent replacement of the picc catheter d/t drug infusions needing to be restarted.No patient harm or complication came from the event, an event report was written up and a new picc line had to be placed.No negative impact occurred to the patient.After transition to the new pavilion icu, a new picc line was established, and the patient received her infusion.
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 a damaged catheter is confirmed and was determined to be use related.The implicated and returned product was 5 fr triple lumen powerpicc.Use residue was observed throughout the sample.The catheter terminated at the 37 cm depth marking.There was a complete fracture on the white lumen extension tubing.The fracture occurred at the luer/tubing joint.Microscopic evaluation of the fracture surface revealed a granular fracture surface.Beach marks, deformation, and radiating tear marks were present on the fracture surface.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT W/GUARDIVA
• 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: 17558361
• Report Number: 3006260740-2023-03566
• Device Sequence Number: 4880345
• Product Code: LJS
• UDI-Device Identifier: 00801741154966
• UDI-Public: (01)00801741154966
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1385108D3
• Device Lot Number: REHN3241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Race: White