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	05/23/2023
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that, "a 4 fr provena kink that is still in the patient that we are manipulating externally as she should finish therapy soon." no other information was provided.
Event or Problem Description
It was reported by customer that, "a 4 fr provena kink that is still in the patient that we are manipulating externally as she should finish therapy soon." no other information was provided.Additional information received on 5/30/2023: customer reported that on (b)(6) at 18:15 blood return sluggish and declotting of both lumens with alteplase was unsuccessful so an x-ray was requested which showed a kink.Gentle pressure on the insertion site improved function.On (b)(6) at 02:00 the line was noted to be hard and sluggish to flush in both lumens.On (b)(6) 2023 the line was removed.Therapy was completed with no issues mentioned by nurses.Catheter had been inserted 12cm above the antecubital fossa with 2cm left external to the patient.The event did not involve an urgent or critical medical situation and did not cause a delay in treatment.There was no patient harm.
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 kinked catheter was confirmed.The product returned for evaluation was one 4fr d/l powerpicc provena catheter.Usage residues were observed throughout the sample.Three kink impressions were observed between the 3cm and 6cm depth markings.The depth markings were worn in the vicinity of the kink impressions.Microscopic inspection of the sample revealed material wear and buckling at the kink sites.The sample kinked easily and preferentially at the kink impression sites during manual manipulation.The impressions appeared to be caused by sharp kinking of the catheter shaft.The use residues and depth marking wear suggested that kinking occurred during device use.The short period between device placement and removal suggested that kinking may have occurred during device placement or securement.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17121789
• Report Number: 3006260740-2023-02415
• Device Sequence Number: 6593590
• 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: 2023
• Device Explanted 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): 10/27/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGZ1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 14 YR
• Patient Sex: Female
• Patient Weight: 54 KG