MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F TL CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); 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	12/29/2016
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, as the device was discarded after the event occurred.A lot history review (lhr) of reaq1020 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Nurse at facility reported that during checks, another nurse noticed that the dressing on a patient with a picc line was moist.When the nurse went to change the dressing, they also tried flushing the catheter.When flushing the white port, they noticed fluid coming out of the insertion site.Nurse stated that they thought that the leak was coming from the catheter inside the patient.The catheter was removed, no new device was placed and no additional medical intervention was required.No patient harm reported.Nurse stated that the grey lumen flushed fine.They did not examine the picc line after it was removed.Nurse stated that staff are educated to use a 10cc syringe for flushing.

• Brand Name: POWERPICC 5F TL CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: 6260786
• Report Number: 3006260740-2017-00006
• Device Sequence Number: 13679671
• Product Code: LJS
• UDI-Device Identifier: 00801741034640
• UDI-Public: (01)00801741034640(17)170728(10)REAQ1020
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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 Expiration Date: 07/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 1385108Q
• Device Lot Number: REAQ1020
• 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: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR