MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT POWERPICC (5F) (DUAL-LUMEN) (70CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Seizures (2063)
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 19ebe168 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (19ebe168) have been reported from the same facility.
Event or Problem Description
It was reported "clinician reported that on two separate occasions, after the picc line was inserted, the patient stated they did not feel right and their eyes started to roll into the back of their head in what seemed like seizure like symptoms.Doctor gave patient oxygen and both patients ended up fine." this report addresses pt#2.

• Brand Name: BARD MYPICC KIT POWERPICC (5F) (DUAL-LUMEN) (70CM)
• 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: 9010150
• Report Number: 3006260740-2019-02655
• Device Sequence Number: 2502923
• Product Code: LJS
• UDI-Device Identifier: 00801741107979
• UDI-Public: (01)00801741107979
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: CK000211D
• Device Lot Number: 19EBE168
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/12/2019
• 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