MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reeq2428 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reeq2428) have been reported from the same facility.
Event or Problem Description
It was reported the picc was inserted 7/4, 7/6 pulled back 1-2cm, then replaced 7/7 for ij malposition.
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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, x-ray analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked catheter was inconclusive due to the sample condition.One x-ray image was provided for evaluation.The upper arm and torso region were shown in the image.A single catheter appears to be present in the arm of the patient.A white arrow is seen on the x-ray pointing to what appears to be a kink in the catheter.The image was forwarded to a radiologist consultant for further review who stated, ¿i can not tell if there is a kink at the insertion of the catheter into the arm because overlap of catheter can also give this appearance.¿ as it was unclear in the x-ray if there was a kink at the insertion site or if it was due to the overlap of the catheter, the complaint cannot be confirmed at this time.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.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the picc was inserted 7/4, 7/6 pulled back 1-2cm, then replaced 7/7 for ij malposition.

• Brand Name: POWERPICC PROVENA SOLO 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
• MDR Report Key: 10677129
• Report Number: 3006260740-2020-20097
• Device Sequence Number: 14483972
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: S1395108D3
• Device Lot Number: REEQ2428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR