MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); 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	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of refq1088 showed two other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by customer "vascular access team called to troubleshoot picc just exchanged this morning.Upon assessment, picc completely occluded and unable to flush or draw blood.X-ray image obtained showing similar kinking of catheter with previous line." 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 by customer "vascular access team called to troubleshoot picc just exchanged this morning.Upon assessment, picc completely occluded and unable to flush or draw blood.X-ray image obtained showing similar kinking of catheter with previous line." no other information was provided.Additional information received 2/28/2023: it was reported by the customer "datheter was secured with securacath.".
Event or Problem Description
It was reported "line placed (b)(6) 2022.1/5 declot x 2 not successful on (b)(6) during removal picc rn could feel a kink just release as picc was withdrawn.Xray image does not show arm of patient but of note tip positioning is short." it was stated device was secured with catheter was secured with securacath.
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.
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 kinked catheter was confirmed but the cause is unknown.A single ap radiographic image of the right side of the chest and upper right arm was returned for evaluation of this complaint.The implicated product was a right-side placed 4fr d/l powerpicc provena catheter.There appeared to be kink in the line at the skin surface and probably at the entrance into the vein.It is likely that the kink in the catheter caused the difficulty infusing through the catheter.Possible contributing factors could include the angle of the catheter as it entered the vein, 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 h11.
Event or Problem Description
It was reported "line placed on (b)(6) 2022.1/5 declot x 2 not successful on (b)(6) during removal picc rn could feel a kink just release as picc was withdrawn.Xray image does not show arm of patient but of note tip positioning is short." it was stated device was secured with catheter was secured with securacath.
Event or Problem Description
It was reported "line placed (b)(6) 2022.1/5 declot x 2 not successful on 1/7 during removal picc rn could feel a kink just release as picc was withdrawn.Xray image does not show arm of patient but of note tip positioning is short." it was stated device was secured with catheter was secured with securacath.Additional information received 5/25: catheter was placed 12cm above the antecubital fossa with 4cm left external to the patient.
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.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16475616
• Report Number: 3006260740-2023-00638
• Device Sequence Number: 7250524
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/31/2023

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: S1274108D1
• Device Lot Number: REFQ1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 04/13/2023; 05/17/2023; 05/25/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/27/2023; 04/27/2023; 05/23/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: 14 YR
• Patient Sex: Unknown
• Patient Weight: 43 KG