MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pain (1994)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0777 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s "caller states she has powerpicc solo 3194335.Caller asking what the picc line is used for and where it should be placed.How long will it stay in? caller states she is in the hospital right now and they did not give her too much information.Does it cause blood clots? caller asking if she needs to take medication to keep from getting blood clots now that she has a picc line.How do i know i'm not "rejecting" the picc? caller states the picc (3194335, lot # refs0777).Ms&s explained that the powerpicc is used to give iv medication, iv fluids and for blood draws.Explained there is no set dwell time for piccs and that her doctor will need to decide when the picc should come out based on clinical indications.Explained that we do not have a recommendation for taking a medication to prevent blood clots.Piccs do not cause blood clots but patients can acquire a clot in or near the picc itself.Her doctor will need to monitor her closely and provide interventions to prevent blood clots while in the hospital.Caller states she is having soreness and shortness of breath and the doctor's are "dismissing" her now.Explained that if she is allergic to the materials in the picc she could have symptoms like hives, shortness of breath, itching, skin redness.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN)
• 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: 12626026
• Report Number: 3006260740-2021-04348
• Device Sequence Number: 16986602
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3194335
• Device Lot Number: REFS0777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/13/2021
• 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: Required Intervention