MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
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 reft3500 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported on friday, (b)(6) 2022, about 5pm, during the insertion of a picc catheter, there was an occurrence during its use.Picc catheter was attempted to be placed in adult patient (above 60 years old), impatient in the facility.After several unsuccessful attempts to advance the catheter until its mark zero, the catheter was removed from the vein to restart the procedure from the beginning, and then it was noticed that its distal end (the last 5-7 cm) was with memory (an "addicted" position).So, the hydrophilic stylet was removed as well until its end so it could be evaluated, and it was presenting a fracture in its distal end.Initially, the catheter was cut in 43cm.However, in the firsts insertion attempts it was not advancing till its end, and there was always 11cm remaining outside.Due to the advancing failures, the entire catheter was removed and evaluated throughout its length, and at this moment it was identified the memory, at the same moment the stylet was removed to be evaluated.The second cut of the catheter (more 11cm were cut away), was performed after the removal of the stylet.It was evaluated more closely and it was confirmed the fracture of the hydrophilic stylet, so it was removed and no longer used to catheter placement.Customer highlights that prior the catheter insertion attempt, it was performed a visual inspection and fulfill of the catheter's prime with saline solution 0.9%.The catheter was kept aligned on the tray and no issue/memory was observed in it.Additionally, for the catheter cut, it was performed the removal of the stylet keeping outside 2/3 of its length, assuring the stylet was not at the point the catheter was cut.It was observed that the hydrophilic stylet was untouched after the catheter was cut, attending to the needing of keeping it so its technology could be entirely used (by surfing and confirmation of intracavitary catheter tip).The catheter insertion was performed without the hydrophilic stylet, so the patient, users, and professionals would not be under any risk.
Event or Problem Description
It was reported on (b)(6) 2022, about 5pm, during the insertion of a picc catheter, there was an occurrence during its use.Picc catheter was attempted to be placed in adult patient (above 60 years old), impatient in the facility.After several unsuccessful attempts to advance the catheter until its mark zero, the catheter was removed from the vein to restart the procedure from the beginning, and then it was noticed that its distal end (the last 5-7 cm) was with memory (an "addicted" position).So, the hydrophilic stylet was removed as well until its end so it could be evaluated, and it was presenting a fracture in its distal end.Initially, the catheter was cut in 43cm.However, in the firsts insertion attempts it was not advancing till its end, and there was always 11cm remaining outside.Due to the advancing failures, the entire catheter was removed and evaluated throughout its length, and at this moment it was identified the memory, at the same moment the stylet was removed to be evaluated.The second cut of the catheter (more 11cm were cut away), was performed after the removal of the stylet.It was evaluated more closely and it was confirmed the fracture of the hydrophilic stylet, so it was removed and no longer used to catheter placement.Customer highlights that prior the catheter insertion attempt, it was performed a visual inspection and fulfill of the catheter's prime with saline solution 0.9%.The catheter was kept aligned on the tray and no issue/memory was observed in it.Additionally, for the catheter cut, it was performed the removal of the stylet keeping outside 2/3 of its length, assuring the stylet was not at the point the catheter was cut.It was observed that the hydrophilic stylet was untouched after the catheter was cut, attending to the needing of keeping it so its technology could be entirely used (by surfing and confirmation of intracavitary catheter tip).The catheter insertion was performed without the hydrophilic stylet, so the patient, users, and professionals would not be under any risk.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was four photographs which depicted an ecg stylet.All four photographs depicted the distal end of the stylet.Curved shape memory and kinks were evident throughout the plastic-coated region.The tip of the stylet appeared to be broken.The fourth photograph also depicted the distal end of the stylet and the distal broken fragment from within the plastic-coated region.Stylet damage was evident in the submitted photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause uknown¿ at this time.Potential contributing factors include sharp instrument damage and inserting the tip of the stylet past the catheter tip during catheter insertion.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13639205
• Report Number: 3006260740-2022-00548
• Device Sequence Number: 14721420
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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 Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 1295118
• Device Lot Number: REFT3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: Female