MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOL G; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reer0510 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reer0510) have been reported from the same facility.
Event or Problem Description
It was reported via ms&s "caller places a lot of powerpicc solo catheters.Last week they placed a powerpicc solo in a patient and sent the patient back to the nursing home.The picc occluded immediately and had to be replaced and the second solo picc also occluded.He is wondering if they can lock the solo with some heparin? both were product codes 3194335 lot number reer0510." ms&s responded "confirmed that heparin may be needed in some patients and is not contraindicated.They use the neutron needleless connector".This report addresses the first picc that occluded.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOL G
• 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: 10518508
• Report Number: 3006260740-2020-03216
• Device Sequence Number: 16782925
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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 Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 3194335
• Device Lot Number: REER0510
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1