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	07/15/2020
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 one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported the picc line was placed on 07/04 but kinked in the patient's arm, preventing the nurse from being able to flush or draw on 07/15.The nurse pulled the picc and exchange it.
Event or Problem Description
It was reported the picc line was placed on 07/04 but kinked in the patient's arm, preventing the nurse from being able to flush or draw on 07/15.The nurse pulled the picc and exchange it.Additional info.Rec'd: picc placed 6/29/20.On (b)(6) 2020, picc was ¿positional¿.When manual pressure applied at site, catheter flushed and had blood return.When pressure released, it would not flush or draw back blood.Removed.New picc placed in other arm, per md request.Medwatch rcvd (b)(6) 2020: patient care rn complained picc was "positional".Unable to flush or draw blood unless arm positioned against chest.When manual pressure applied to siste.Picc would flush and draw blood ok.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx1880 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

• 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: 10370932
• Report Number: 3006260740-2020-02775
• Device Sequence Number: 14226540
• 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,Followup
• Report Date (Section B): 09/29/2020
• Report Date (Section F): 07/20/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91
• Date Report Sent to FDA: 07/20/2020