MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DL) (135CM NITINOL GUIDEWIRE); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
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 rebr1161 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient came into clinic to receive a push iv antibiotic (ceftriaxone) and a hpt bag change (vancomycin).The red port of the picc was allegedly occluded and only the purple port was being used.Nurse stopped the hpt pump, disconnected and capped the hpt line.The purple port was disinfected and flushed again.It was stated it flushed with a great deal of resistance, so the nurse stopped flushing.Nurse tried to aspirate for blood return and there was no flashback.Patient could not receive either of the two antibiotics.Patient was sent to family doctor and then to emergency department to receive tpa.No other information was provided.No patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DL) (135CM NITINOL GUIDEWIRE)
• 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: 7033363
• Report Number: 3006260740-2017-02031
• Device Sequence Number: 1014223
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3295335
• Device Lot Number: REBR1161
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1