MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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 reeu1427 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc inserted on (b)(6) 2021 had to be replaced due to a hole in the catheter.It was further reported that the hole is located close to the end where it butterflies to the skin.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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), 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 hole in the catheter was confirmed.The product returned for evaluation was a 5fr d/l powerpicc solo catheter.The print was worn on the extension legs and on the molded bifurcation of the catheter.The catheter held a curved shape memory between the molded bifurcation and the 12cm depth marking.The catheter shaft was wavy with the apex of the curves being located at the 11cm, 16cm, 19cm, 25cm and 36cm depth markers.Directly distal of the molded bifurcation, the catheter was kinked and collapsed.A semi-circumferential split was seen in the catheter tubing, within the crease of the compressed tubing.Microscopic examination of the split site revealed it to be 0.046¿ long.The edges of the split showed slight wear.The catheter material had white discoloration at the terminating ends of the split.When an attempt was made to flush the catheter with water, both lumens were patent to infusion.A spraying leak was observed from the split in the tubing when the red lumen was flushed, and a bubbling leak was observed emanating from the split in the tubing when the purple luer was flushed.The catheter outer diameter, lumen heights, lumen widths, wall thicknesses and septum thickness were measured at the distal end of the device and were found to meet the device specifications.Examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which placement, usage, securement and mechanical factors may gradually form a crack in the catheter.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.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that a picc inserted on (b)(6) 2021 had to be replaced due to a hole in the catheter.It was further reported that the hole is located close to the end where it butterflies to the skin.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN)
• 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: 11477759
• Report Number: 3006260740-2021-00815
• Device Sequence Number: 3804637
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 3295335
• Device Lot Number: REEU1427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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