MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter kink was confirmed.Based on the observations from the two provided photographs, it appeared that the reported event was associated with use of the product.The catheter shaft of a powerpicc was visible in the photos.A discolored dressing was visible at the proximal end of the catheter shaft where the distal end of the molded wing/bifurcation was visible, which indicates that the product was used.One pronounced kink was observed in the photographs.What appear to be two smaller kinks were observed distal to the well-defined kink.It was reported that the catheter was placed on 5/19 at the 15cm mark and removed on 5/20.Placement of the catheter indicates that the lumens were flushed prior to use.To preflush the catheter, the ifu states, "attach pre-filled syringe to the luer attachment on the t-lock extension set and flush each lumen of catheter with sterile saline." the product ifu also states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ ¿note: maximum recommended insertion is to the zero mark on the catheter shaft.¿ "note: when dressing a picc do not create bends or curves in the catheter shaft that are less than 2 cm in diameter." the insertion and or securement technique may have been contributing factors in the reported event.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc was placed 5/19 in r brachial, left at 15 cm.Removed on 5/20.The tip was not confirmed in caj and left as a midline.Nurse complained that it would not flush several hours after insertion.Picc was removed and noticed to be bent.

• Brand Name: DOT PROV 4F DL MAX
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8697755
• Report Number: 3006260740-2019-01626
• Device Sequence Number: 11227587
• Product Code: LJS
• UDI-Device Identifier: 00801741130403
• UDI-Public: (01)00801741130403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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: S3274108D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1