MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER RADIOLOGY BASIC TRAY (4F) (SINGLE-LUMEN) (N135CM) (N70CM); 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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv1359 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The nurse reported that the powerpicc became occluded within the first 24 hours of placement.No other information was provided.
Event or Problem Description
The nurse reported that the powerpicc became occluded within the first 24 hours of placement.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the catheter became occluded 24 hours after placement was inconclusive due to the sample condition.One 5 fr triple-lumen powerpicc solo was returned for investigation.The catheter was received in two segments.The proximal segment consisted of the solo connectors, extension legs, trifurcation, and the triple-lumen tubing that extended to the 34cm depth mark.Non-vad injection caps had been attached to the solo connectors.The distal catheter segment consisted of triple-lumen tubing that extended from the 34 to the 46cm depth mark.A dry, dark, and red-tinted residue was exiting one of the non-power injectable lumens of the distal catheter segment near the 34cm depth mark.What appeared to be similar residue from use was flushed from another lumen in the distal catheter segment.Whether this residue was occluding the lumen during use was unknown.No kinking was observed in the triple-lumen tubing and no damage associated with the manufacturing process was observed on the returned sample.A functional test revealed additional residue flushed from the power-injectable lumen in the distal catheter segment.Each lumen was patent to infusion and aspiration.The maintenance technique may have been a contributing factor in the reported event.The product ifu provides the following recommended flushing/maintenance procedure.The catheter should be maintained in accordance with standard hospital protocols.Recommended catheter flushing/maintenance is as follows: flush each lumen of the catheter after every use, or at least weekly when not in use.Use a 10 ml or larger syringe.Flush each lumen of the catheter with a minimum of 10 ml of preservative-free 0.9% sodium chloride usp (sterile saline), using a ¿pulse¿ or ¿stop/start¿ technique.Use of heparin flush solution to lock each lumen of the catheter is optional.Disconnect the syringe and attach a sterile end cap to the catheter hub and tighten securely.Prior to blood sampling when infusing tpn, follow routine maintenance procedure except use 20 ml of sterile saline and flush to clear tpn from the catheter.If resistance is met when flushing, no further attempts should be made.Further flushing could result in catheter rupture with possible embolization.Refer to institution protocol for clearing occluded catheters.Caution: to reduce potential for blood backflow into the catheter tip, always remove needles or syringes slowly while injecting the last 0.5 ml of sterile saline.A lot history review (lhr) of recv1359 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER RADIOLOGY BASIC TRAY (4F) (SINGLE-LUMEN) (N135CM) (N70CM)
• 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: 8404945
• Report Number: 3006260740-2019-00517
• Device Sequence Number: 1990507
• Product Code: LJS
• UDI-Device Identifier: 00801741028847
• UDI-Public: (01)00801741028847
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: S1395108D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1