MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING (TPS) STYLET (5F); 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	Tingling (2171); Numbness (2415)
Date of Event	08/05/2020
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 reeq0287 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s: "patient's daughter states the patient received powerpicc solo on 08/05/2020.She reports that the catheter flushes without difficulty and a blood return is noted.The picc is placed in her upper arm.The patient reports experiencing 'shocks with numbness and tingling' from her elbow to her hand on the side of the picc" ms&s response: "discussed causes of these symptoms and recommended she contact the md or the picc team at the hospital where the picc was placed and notify them as soon as possible.Case forwarded to fa via email" additional info.Received 08/24/2020 no harm reported.Weight: "(b)(6)" treated for:" low hemoglobin" other relative history: "difficulty with giving or receiving blood" "patient does not have an infectious disease.".

• Brand Name: POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING (TPS) STYLET (5F)
• 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: 10522613
• Report Number: 3006260740-2020-03238
• Device Sequence Number: 3155604
• Product Code: LJS
• UDI-Device Identifier: 00801741140822
• UDI-Public: (01)00801741140822
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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 Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000502A
• Device Lot Number: REEQ0287
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/11/2020
• 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
• Patient Age: 88 YR
• Patient Weight: 53