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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2023
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
Customer reported a 5fr tl powerpicc provena inserted in the right upper arm basilic vein on (b)(6) 2023.Catheter was tpa'd in one lumen on 4/8 and one on 4/13.Catheter continued to have persistent issues with functionality.Chest x-ray was requested to assess for kink.Kink near the insertion site confirmed on 4/16.Picc was pulled back 2cm on 4/16 and kink resolved.However, picc tip is now in the upper svc and "may need replacement".Picc dwell time was 17 days.
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 catheter kink was confirmed but the cause is unknown.A single ap radiograph showing the patient¿s right arm was returned for evaluation.A catheter, consistent with the implicated 5fr t/l powerpicc provena, was seen in the image.Overlapping of the catheter shaft was seen in this view with a probable kink.It could not be determined from this image if the kink was located at the skin, muscle, or venous insertion site.Possible contributing factors for a kink in the catheter could include the anatomic variables, catheter placement, or catheter securement.The ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ and ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen¿.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The report of a kinked catheter has been documented and will be monitored as part of complaint trending.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
Customer reported a 5fr tl powerpicc provena inserted in the right upper arm basilic vein on (b)(6) 2023.Catheter was tpa'd in one lumen on (b)(6) and one on (b)(6).Catheter continued to have persistent issues with functionality.Chest x-ray was requested to assess for kink.Kink near the insertion site confirmed on (b)(6).Picc was pulled back 2cm on (b)(6) and kink resolved.However, picc tip is now in the upper svc and "may need replacement".Picc dwell time was 17 days.

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER PLUS KIT
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16915588
• Report Number: 3006260740-2023-01824
• Device Sequence Number: 15046887
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S1385108D5
• Device Lot Number: REGS0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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