MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3174108
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebs2657 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the vascular access nurse to ms&s that her patient is having a possible reaction to a powerpicc.It was stated that the patient has cystic fibrosis and multiple allergies.The patient came in for a picc placement on (b)(6) 2018.The patient complained of pain shortly after insertion and the pain intensified over the next day and became severe.The area around the picc became swollen, red and very itchy.There was a 3 cm area around the picc insertion site that was very inflamed.They did an ultrasound and ruled out a dvt.The picc was removed 01/14/18, the redness and swelling are resolving.Ms&s discussed material content of the powerpicc and how patients can also react to the chlorohexidine.

• Brand Name: POWERPICC CATHETER 4F FULL TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7239001
• Report Number: 3006260740-2018-00109
• Device Sequence Number: 1215642
• Product Code: LJS
• UDI-Device Identifier: 00801741027574
• UDI-Public: (01)00801741027574
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: 3174108
• Device Catalogue Number: 3174108
• Device Lot Number: REBS2657
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1