MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM; 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	12/25/2017
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, at this time, for evaluation.A lot history review (lhr) of rebx0351 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they placed a dual lumen picc on (b)(6) 2017 in a patient in the micu.It was stated that on (b)(6) 2017 the purple lumen side came unattached to the y-hub and the picc had to be pulled.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the extension leg broke at or near the connector was confirmed, but the exact cause was unknown.One 5fr d/l powerpicc was returned for investigation.The catheter exhibited evidence of use.Dry blood residue was observed within the catheter and a tacky residue, which appeared to be from tape or a dressing, was observed on the external surface of the extension legs.The printing on the extension legs was partially worn.The d/l catheter tubing had been cut 2mm distal to the bifurcation and the distal segment of catheter was not returned for investigation.The extension leg with the red connector was complete.The other extension leg was missing its connector.The purple connector was not returned for investigation.The extension leg with the missing connector extended 6.6cm from the proximal end of the bifurcation.The cross section of the damaged end of the extension leg was microscopically examined and was noted to be jagged and granular.A 5mm section of the external surface of the extension leg adjacent to the damaged end of the tubing exhibited a dull appearance.The remainder of the extension leg was glossy and reflective.It is possible that the break occurred 5mm within the distal end of the purple connector.The attachment between the other extension leg and the red connector revealed nothing remarkable.No evidence was found on the returned sample and in the manufacturing records of the reported lot that the damage was associated with the manufacturing process.Potential contributing factors of the damage include pulling, twisting, and/or manipulating the connector.A lot history review (lhr) of rebx0351 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they placed a dual lumen picc on (b)(6)2017 in a patient in the micu.It was stated that on (b)(6) 2017 the purple lumen side came unattached to the y-hub and the picc had to be pulled.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM
• 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: 7195281
• Report Number: 3006260740-2017-02437
• Device Sequence Number: 10996297
• Product Code: LJS
• UDI-Device Identifier: 00801741035685
• UDI-Public: (01)00801741035685
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 9275108
• Device Lot Number: REBX0351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1