MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER, 4F SL 3CG; 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
A lot history review (lhr) of redx0525 showed no other similar product complaint(s) from this lot number.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.
Event or Problem Description
It was reported via ms&s "patient received picc ck000897 (lot# redx0252) last tuesday.She is receiving daily treatment and reports her picc is sluggish." ms&s spoke with nurse at infusion center who states the picc flushed without difficulty and a blood return is noted."it is just a bit slow".The nurse states the facility protocol in place uses tpa and dye studies if needed.

• Brand Name: POWERPICC CATHETER, 4F SL 3CG
• 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: 10118563
• Report Number: 3006260740-2020-01958
• Device Sequence Number: 3082684
• Product Code: LJS
• UDI-Device Identifier: 00801741184925
• UDI-Public: (01)00801741184925
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000897
• Device Lot Number: REDX0525
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1