MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER BARRIER PLUS KIT W/BIOPATCH; 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx0108 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "stylet checked prior to insertion.Picc inserted in pt.'s left arm, some minor insertion difficulty noted advancing past subclavian area, resolved easily with repositioning pt.'s left arm.Stylet checked upon removal from picc after picc successfully inserted and kink noted within last 2cm of stylet (recognized visually and tactilely).".
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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed no blood residue on the returned sample.Bends were observed in the returned stylet approximately 1 cm and 3.6 cm proximal to its distal tip as well as approximately 20.2 cm distal to the yellow handle of the stylet.No breaks were observed in the core wire of the stylet and the distal tip was found to be present and intact.A microscopic observation revealed no breaks or tears in the tubing at the distal end of the stylet, and the slight bends within this tubing were found to be near the interfacing of two magnets.Insufficient evidence was found on the returned sample to indicate a specific root cause of the bends in the returned stylet; however, possible contributing factors include advancement of the stylet against resistance and damage during manipulation, handling, or use.A lot history review (lhr) of refx0106 showed two other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "stylet checked prior to insertion.Picc inserted in pt.'s left arm, some minor insertion difficulty noted advancing past subclavian area, resolved easily with repositioning pt.'s left arm.Stylet checked upon removal from picc after picc successfully inserted and kink noted within last 2cm of stylet (recognized visually and tactilely).".

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14053573
• Report Number: 3006260740-2022-01202
• Device Sequence Number: 14603281
• Product Code: LJS
• UDI-Device Identifier: 00801741155123
• UDI-Public: (01)00801741155123
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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: S1395108D4
• Device Lot Number: REFX0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown