MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC WITH SHERLOCK 5F DUAL-LUMEN POLYURETHANE CATHETER WITH TLS STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Chest Pain (1776); Foreign Body In Patient (2687)
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, as the device remains in the patient.A lot history review (lhr) of revf0983 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch that the patient was in the icu seven years ago with trauma, and a bard picc line was placed in the left arm by the nurse from iv therapy.The patient pulled the first picc out and a second was placed four days later.The second picc was removed at the time of discharge without incident.Last month the patient returned to the hospital with complaints of chest pain.A ct of the chest confirmed two foreign bodies about 2cm in length with one located in the right ventricle and the other in a small branch of the pulmonary artery near the middle of the right lung.After review of x-rays from seven years prior it was discovered that the foreign material was present after the placing of the first picc line.

• Brand Name: POWERPICC WITH SHERLOCK 5F DUAL-LUMEN POLYURETHANE CATHETER WITH TLS STYLET
• 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: 7289649
• Report Number: 3006260740-2018-00252
• Device Sequence Number: 1044768
• Product Code: LJS
• UDI-Device Identifier: 00801741035739
• UDI-Public: (01)00801741035739
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2018
• Report Date (Section F): 01/01/2018

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: N/A
• Device Catalogue Number: 9275118
• Device Lot Number: REVF0983
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2018
• 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: 16 YR
• Date Report Sent to FDA: 01/01/2018