MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO HF CATHETER W/SHERLOCK TPS STYLET 5F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez1102 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by health professional "friday sept 10th, i attempted to place a triple lumen picc line.I accessed the vein easily and the wire advanced fine as well as the introducer.I had some difficulty advancing the picc line from the beginning, but i then was able to get it to approximately the subclavian area.It would not go any further.I did pull out the tps stylet about halfway and then re-advanced it to see where the picc ended by looking at sherlock.I did this approximately 3-4 times.I then left the catheter in place and removed the tps stylet.I did not notice that any of the stylet wire was missing.I knew i was not in the svc, but i wasn't sure where the tip of the picc was at, so i obtained a cxr.I didn't want to pull the picc as the patient was a very ill covid patient who was close to needing intubation.I was able to flush the catheter and aspirate blood.On the cxr i could see wire sticking out of the picc line.The patient then had to go to ir and have the wire and picc line removed." additional information received 09/16/2021: was there any patient harm reported? yes.What they're being treated for: hypercapnic respiratory failure and covid does the patient have an infectious disease?: yes.
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 a break in the stylet during the insertion procedure was confirmed but the cause is unknown.The product returned for evaluation was a 3cg stylet.The stylet was received in two segments, with a complete break in the magnetic region of the stylet.The solid core wire contained a kink proximal of the t-lock assembly and a curled section between the t-lock assembly and the magnetic region.A kink was noted in the magnetic region of the proximal segment 0.3¿ proximal of the break.The kinks in the stylet may indicate that the stylet and/or catheter was advanced against resistance or through a tortuous path.No kinks or bends were noted in the distal segment of the stylet.The outer plastic tubing of the stylet was measured, and it was confirmed that the wall thickness of the material met the device specifications.The edges of the break sites were slightly jagged and irregular.The outer plastic tubing was slightly bent out of round in these regions which may indicate that the tubing was kinked prior to breaking.It was reported that difficulty was felt during catheter advancement.In addition, the stylet was retracted and advanced multiple times.This may have contributed to the stylet breakage.However, the cause of the initial difficulty during advancement could not be determined.It is possible that the difficult placement was a contributing factor in the stylet break.However, it is unknown if additional unknown factors contributed to this event.H3 other text : device evaluation findings are in the manufacturer's note.
Event or Problem Description
It was reported by health professional "friday sept 10th, i attempted to place a triple lumen picc line.I accessed the vein easily and the wire advanced fine as well as the introducer.I had some difficulty advancing the picc line from the beginning, but i then was able to get it to approximately the subclavian area.It would not go any further.I did pull out the tps stylet about halfway and then re-advanced it to see where the picc ended by looking at sherlock.I did this approximately 3-4 times.I then left the catheter in place and removed the tps stylet.I did not notice that any of the stylet wire was missing.I knew i was not in the svc, but i wasn't sure where the tip of the picc was at, so i obtained a cxr.I didn't want to pull the picc as the patient was a very ill covid patient who was close to needing intubation.I was able to flush the catheter and aspirate blood.On the cxr i could see wire sticking out of the picc line.The patient then had to go to ir and have the wire and picc line removed.".

• Brand Name: POWERPICC SOLO HF CATHETER W/SHERLOCK TPS STYLET 5F MAXIMAL BARRIER TRAY
• 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: 12598161
• Report Number: 3006260740-2021-04298
• Device Sequence Number: 16987582
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1395108QD
• Device Lot Number: REEZ1102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 51 KG