MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER); 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	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reev2080 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the provena catheter was removed due to a mechanical occlusion.The catheter was kinked twice, at the 2cm and 4cm mark.Patient had an arm circumference of 43cm, the picc kinked in the adipose tissue.It started having issues the very next day after insertion.They tried cathflo without success.The picc was in at the hub and 0 mark.
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, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked catheter was confirmed.The product returned for evaluation was a 4fr d/l powerpicc catheter in two segments (cut at the 25cm depth marker).The depth markers between 0cm and 5cm were slightly worn.Circumferential impressions were seen in the catheter tubing at the 2cm and 4cm depth markings.These impressions were consistent with deformation from the catheter being previously kinked.When the catheter was bent back upon itself with approximately a 2 cm bend, the catheter would preferentially kink at the 4cm depth marking but did not appear to preferentially kink at the 2cm depth marking.Microscopic examination of the impressions confirmed that there were semi-circumferential creases in these locations.The catheter lumen height, wall thickness and septum thickness were measured at the proximal and distal end of the catheter and were confirmed to meet the device specifications.It appears that the catheter was kinked during use.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 h11.
Event or Problem Description
It was reported the provena catheter was removed due to a mechanical occlusion.The catheter was kinked twice, at the 2cm and 4cm mark.Patient had an arm circumference of 43cm, the picc kinked in the adipose tissue.It started having issues the very next day after insertion.They tried cathflo without success.The picc was in at the hub and 0 mark.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER)
• 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: 10908713
• Report Number: 3006260740-2020-20705
• Device Sequence Number: 11008449
• Product Code: LJS
• UDI-Device Identifier: 00801741154843
• UDI-Public: (01)00801741154843
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: S1274108D2
• Device Lot Number: REEV2080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 03/15/2021
• 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