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

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regt3425 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.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.
Event or Problem Description
It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.No other information was provided.
Event or Problem Description
It was reported, crack in clear t-port which is what the stylet goes through, picc had to be exchanged for a new one.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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged t-lock assembly was confirmed; however, the root cause was not identified.The product returned for evaluation was one 5fr d/l powerpicc catheter.The sample was received with an inlaid stylet and attached t-lock assembly.The wire had been manipulated within the t-lock septum and a sharp bend was observed in the wire just proximal of the t-lock.The septum appeared concave at the wire exit site and was partially dislodged from the t junction.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed at the t-lock assembly due to the dislodgement.Microscopic inspection of the sample confirmed deformation and dislodgement of the t-lock assembly septum.The t-lock assembly septum was easily fully detached from the t-lock during gentle manipulation.The shrink tubing was also easily manipulated.Deformation and dislocation of the t-lock septum was observed and resulted in leakage; however, the cause of that deformation was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The bend in the wire suggested that manipulation may have contributed, which may have occurred prior to or during attempted use.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA 5F DL FT 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16425152
• Report Number: 3006260740-2023-00517
• Device Sequence Number: 6919571
• Product Code: LJS
• UDI-Device Identifier: 00801741154850
• UDI-Public: (01)00801741154850
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2023

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 Model Number: N/A
• Device Catalogue Number: S1275108FD2
• Device Lot Number: REGT3425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 04/26/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/03/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Sex: Unknown