MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9295108D
Health Effect - Clinical Codes	Dyspnea (1816); 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 was discarded after the event occurred.A lot history review (lhr) of rexg2283 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
Facility contact reported that a patient had a picc placed in (b)(6) 2013 for three days.The picc was removed once treatment had concluded and the patient was sent home ok.In (b)(6) 2016, the patient came to the same hospital with shortness of breath.A ct was done which showed 3-4 cm of a metallic object embedded in the pulmonary artery.Nurse was unsure if this object was from the picc line from three years ago or from a previous cvc catheter implanted and removed before the picc.Contact stated that there are no plans to remove the object at this time as it would require open heart surgery.

• Brand Name: 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT
• 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: 5464796
• Report Number: 3006260740-2016-00060
• Device Sequence Number: 593185
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760(17)150228(10)REXG2283
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K0702230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2016

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: 02/28/2015
• Device Catalogue Number: 9295108D
• Device Lot Number: REXG2283
• 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: 02/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1