MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUIDEW; 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp1307 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was initially trimmed at 32 cm but would not advance therefore catheter was trimmed to 10 cm to be left as a midline.It was stated when they went to aspirate, there sounded like there was air releasing from the extension legs.The catheter was removed and another catheter was placed without difficulty.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a breach in the catheter that would allow air to enter the extension legs during aspiration was unconfirmed.One 5fr dual-lumen (d/l) powerpicc ft was returned for investigation.Evidence of use was observed on the catheter.A red-colored residue was visible in one extension leg.The d/l tubing had been trimmed to length 11.4cm from the distal end of the molded bifurcation hub.A functional test revealed that each lumen of the catheter was patent to infusion.Under sustained hydraulic pressure, no leaks were observed in any part of the returned picc.Since no breach was observed in the catheter, the complaint was unconfirmed.The instructions for use (ifu) warn, ¿for powerpicc® ft catheters, do not trim the catheter shorter than 30 cm.¿ it is possible that the shorter length tubing was a factor in the reported event.When aspirating one lumen and the catheter tip is partially obstructed (e.G.Against the vessel wall) and the adjacent lumen is open (i.E.Unclamped), air can be drawn in from the open lumen at the tip of the catheter.Whether this was a contributing factor was unknown; however, no damage or defects associated with the manufacturing process were observed in the returned sample.
Event or Problem Description
It was reported that the catheter was initially trimmed at 32 cm but would not advance therefore catheter was trimmed to 10 cm to be left as a midline.It was stated when they went to aspirate, there sounded like there was air releasing from the extension legs.The catheter was removed and another catheter was placed without difficulty.

• Brand Name: POWERPICC FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUIDEW
• 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: 8819308
• Report Number: 3006260740-2019-02146
• Device Sequence Number: 11472938
• Product Code: LJS
• UDI-Device Identifier: 00801741027956
• UDI-Public: (01)00801741027956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 3275335F
• Device Lot Number: REDP1307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1