MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	1194108D
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Tingling (2171); Discomfort (2330); Numbness (2415)
Type of Reportable Event	Death
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 rezj1232 no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - it was reported by complainant (patient¿s daughter), that when the power picc was placed, the patient experienced numbness in her left arm, and tingling in her left fingers.The patient went into cardiac arrest and passed away.Complainant was asking if the power picc could cause her mother to pass away.On (b)(6) 2016 - per phone conversation with complainant, patient had picc line placed and had been using it for approximately 2 weeks without issue.The complainant states the patient passed away from cardiac arrest but did not know the cause of the cardiac arrest.Patient did tell complainant that she had some discomfort in her shoulders and hand after placement of the second picc line but complainant is unsure if these discomforts subsided or not.Complainant expressed concern about picc lines being placed in the heart (it is unknown why or how complainant came to this conclusion) and whether this could have been the cause of the patient¿s cardiac arrest as the patient did not have a history of heart problems.Informed complainant that picc lines are not intended to be placed in the heart but that the tip of the catheter rests in the superior vena cava.After a picc is placed, the catheter tip placement is confirmed to be in the correct position, usually by x-ray.Complainant expressed relief and verbalized understanding.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5619647
• Report Number: 3006260740-2016-00193
• Device Sequence Number: 16219990
• Product Code: LJS
• UDI-Device Identifier: 00801741027819
• UDI-Public: (01)00801741027819(17)170428(10)REZJ1232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2016

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: 04/28/2017
• Device Catalogue Number: 1194108D
• Device Lot Number: REZJ1232
• 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: 04/29/2016
• 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: Death