MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108D5
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 reez3810 showed two 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 "my team is reporting issues with our 5 fr triple lumen picc lines, lot reez3810.They are kinking in the arm and we've had to replace 3 in the last week.My team seems to think it is a catheter related issue." this report addresses the first patient.Picc placed (b)(6) 2021 @ 1100 without complication.(b)(6) 2021 at 1300 ivt paged for drainage for site.Rn noted kink in catheter at insertion site, dressing changed.(b)(6) 2021 1730 ivt paged for sluggish blood draws/difficulty with flushing.Again noted kink at insertion site, dressing changed.Chest xray to verify placement (kinked picc line visible on chest xray just proximal to insertion site although this was not indicated in initial radiology report it was found after the fact by ivt rn.) (b)(6) 2021 picc line will not draw/flush, retracted until able to obtain blood return.(b)(6) 2021 picc line continues to drain from insertion site, continued issue with flushing.Picc dc'd and replaced on alternate arm.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11939493
• Report Number: 3006260740-2021-02195
• Device Sequence Number: 11648458
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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 Model Number: S1395108D5
• Device Catalogue Number: S1395108D5
• Device Lot Number: REEZ3810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 64