MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROVPPSOLO 4FDL MBP; 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)
Date of Event	07/03/2020
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 redx1880 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (redx1880) have been reported from the same facility.
Event or Problem Description
It was reported the picc was "placed 7/3 at 16:10, did not use it.At 18:30, rn complained unable to flush.Upon assessment, it would not flush.After applying manual pressure to site, it flushed well.Picc retracted 2 cm and flushed well.Later, night rn had difficulty and applied coban around site and catheter is reportedly working good now.".

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: 10488801
• Report Number: 3006260740-2020-03096
• Device Sequence Number: 2567658
• Product Code: LJS
• UDI-Device Identifier: 00801741154898
• UDI-Public: (01)00801741154898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S1294108D2
• Device Lot Number: REDX1880
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1