MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA CATHETER W/SOLO VALVE TECH AND TPS 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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) of refn2120 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the guidewire appears to be bent or broken, this occurred during placement." no other information provided.
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), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent stylet is confirmed.One 5 fr triple lumen powerpicc provena solo catheter with a 3cg stylet inserted into the red lumen was returned for evaluation.An initial visual observation showed use residue on the returned sample.A bend was observed in the catheter near the 19 cm depth marker and the stylet within this location of the catheter was found to be bent once it was removed.Some shape memory was observed in the catheter near the 19 cm depth marker after the stylet was removed.About 21.5 cm of the stylet was protruding from the t-lock, and two bends were observed in this portion of the stylet approximately 20 cm and 21.5 cm distal to the yellow handle.The locations and physical characteristics of the bends observed in the returned stylet as well as the indication from the complainant that the reported event occurred during the placement procedure suggests the stylet was likely damaged during use.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via phone call "the guidewire appears to be bent or broken, this occurred during placement.Patient has since passed away, unrelated to the device malfunction.Patient has since passed away, unrelated to the device malfunction.".

• Brand Name: POWERPICC PROVENA CATHETER W/SOLO VALVE TECH AND TPS 5F TL
• 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: 12136922
• Report Number: 3006260740-2021-02649
• Device Sequence Number: 4751704
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: S1395108D
• Device Lot Number: REFN2120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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