MAUDE Adverse Event Report: C. R. BARD, INC. POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	S1294108D5
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Picc line in the special needs patent it was not a difficult placement but did have some difficulty getting in down into the svc.The tip of the picc per the sherlock image went straight across or curved back on itself a few times before descending into the svc.Because of the special needs aspect of the patient and physical attributes the picc line had to be removed and trimmed 3 times total to achieve proper length.But it went down into the proper svc placement.After placing the line i was putting the dressing on and gathering my sharps when i notice the tip of the 3cg stylet was not intact.I quickly withdrew 10 ml blood hoping it would withdraw the tip if it was still in the picc line itself, to no success.I had already flushed the line as part of the conformation procedure for place the picc line.I did carefully look around on my sterile field to see if i could see the tip but did not see it.It appears approximately 3 cm is missing when compared to an intact 3cg stylet.I finished the remanded of the procedure.I notified the nurse and requested a pcxr, which was done and also talked with provider.The chest xr did show a possible metallic object and recommended a ct for more details.X-ray: linear densities overlying the left midchest region and right abdominal region.These could represent foreign bodies, or external artifact.Ct may be of value to further assess.Ct chest 1: there is a linear metallic density involving the lingular region measuring 1.8 cm.X-ray: small metallic foreign body is still projecting overlying the lingula 1.3 cm.Picc line is in the right atrium.Fda safety report id (b)(4).

• Brand Name: POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 15321272
• Report Number: MW5111783
• Device Sequence Number: 20290006
• Product Code: LJS
• UDI-Device Identifier: 00801741155208
• UDI-Public: 00801741155208
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 03/31/2023
• Device Model Number: S1294108D5
• Device Catalogue Number: S1294108D5
• Device Lot Number: REFY1271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2022
• 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: 19 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White