MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported picc migrated into jugular, flushed line and pulled back to reposition.What type of catheter securement was utilized? bard picc stat lock and 3m tegaderm iv advanced securement.Placement date: (b)(6) 2021, explant date: in place.
Event or Problem Description
It was reported picc migrated into jugular, flushed line and pulled back to reposition.What type of catheter securement was utilized? bard picc stat lock and 3m tegaderm iv advanced securement.Placement date: 1/20/21.Explant date: in place.
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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter kinking was confirmed but the cause is unknown.The product returned for evaluation was a zoomed in view of the left arm likely from a frontal chest radiograph.There was a left sided picc present.Near the skin surface there was an apparent kink in the catheter at the insertion site.There was also mention of a malposition of the catheter tip in the complaint information.However, the distal end of the catheter was not visible in the returned image.It could not be determined where the trajectory of the catheter was going from this image.Possible contributing factors for a malposition of the catheter tip could include the patient¿s anatomy and/or physiology, jetting of fluid from catheter tip during power injection, or catheter whipping during power injection.The cause of the visible kink in the catheter is unknown at this time.Possible contributing factors could include patient anatomy, catheter placement through a tortuous path, or catheter stabilization.The ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ and ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.¿ a lot history review (lhr) of reew0795 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT W/BIOPATCH
• 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: 11642451
• Report Number: 3006260740-2021-01239
• Device Sequence Number: 11544398
• Product Code: LJS
• UDI-Device Identifier: 00801741155086
• UDI-Public: (01)00801741155086
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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,Followup
• Report Date (Section B): 05/12/2021

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: N/A
• Device Catalogue Number: S1193108D5
• Device Lot Number: REEW0795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: 50 YR
• Patient Weight: 79