MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaz1009 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported picc was placed on (b)(6) 2017, in the right basilic vein.Picc was verified with chest x-ray due to onset afib.Tip was seen to be at the mid-lower svc (2-3 cm above caj).Nurse was called on day 7 stating picc has had intermittent problems and had been cathflowed two times.On day 7 the picc completely stopped working.Chest x-ray was done and picc was proximal svc, 8 cm from caj.Original dressing was intact and picc remained 0 cm out.Picc was replaced on (b)(6) 2017.
Additional Manufacturer Narrative
Correction: initial medwatch was submitted as a second event, upon further information it was found that this medwatch 3006260740-2017-01143 is a duplicate file and has been voided.The event and investigation results have been submitted on medwatch 3006260740-2017-01107.
Event or Problem Description
Facility reported picc was placed on (b)(6) 2017, in the right basilic vein.Picc was verified with chest x-ray due to onset afib.Tip was seen to be at the mid-lower svc (2-3 cm above caj).Nurse was called on day 7 stating picc has had intermittent problems and had been cathfloed two times.On day 7 the picc completely stopped working.Chest x-ray was done and picc was proximal svc, 8 cm from caj.Original dressing was intact and picc remained 0 cm out.Picc was replaced on (b)(6) 2017.

• Brand Name: 4F SL POWERPICC 3CG MB
• 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: 6746771
• Report Number: 3006260740-2017-01143
• Device Sequence Number: 1371687
• Product Code: LJS
• UDI-Device Identifier: 00801741105173
• UDI-Public: (01)00801741105173
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 02/28/2018
• Device Model Number: CK000537
• Device Catalogue Number: CK000537
• Device Lot Number: REAZ1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 120