MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR. S/L POWERPICC - NURSING FULL (TLS); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9174108
Health Effect - Clinical Codes	Pain (1994); Thrombosis (2100)
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 reaw1840 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the patient was leaving the facility she complained of pain in her left arm.Under ultrasound it was noted that the patient had dvt in the left arm.Picc was placed in the left basilic vein.Patient is currently receiving antibiotic therapy.

• Brand Name: 4 FR. S/L POWERPICC - NURSING FULL (TLS)
• 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: 6513556
• Report Number: 3006260740-2017-00498
• Device Sequence Number: 612928
• Product Code: LJS
• UDI-Device Identifier: 00801741035548
• UDI-Public: (01)00801741035548(17)180331(10)REAW1840
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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: 03/31/2018
• Device Catalogue Number: 9174108
• Device Lot Number: REAW1840
• 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: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1