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	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
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 redx1880 showed two 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 "this picc was placed on 06/30, on 07/30 the rn was unable to flush both ports.Rn tried cathflo last night without success.When manual pressure applied above site, catheter flushed well and had good blood return.When pressure released, it would not flush or draw back blood.Retracted 2 cm and has good blood return and flush." (b)(6) 20 catheter continued to be sluggish, almost to the point you could not flush at all.Chest x-ray obtained that included the arm, that revealed a kink.Patient needs the line for long term antibiotics so the line was replaced." additional info.Received 08/05/2020, "what type of catheter securement was utilized? statlock that was supplied with the picc kit." "was there patient harm reported? no.".

• 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: 10460875
• Report Number: 3006260740-2020-03060
• Device Sequence Number: 11478667
• 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
• Device Explanted 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): 08/27/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 80