MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recv2497 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc was found leaking when doing flush test, a leak was from the base of catheter near the suture wing.No patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed but the cause was undetermined.One 5 fr dual-lumen (d/l) powerpicc was returned for investigation.The d/l tubing extended just beyond the 29 cm depth mark, which indicates that the catheter length had been modified.A breach was observed in the d/l tubing just distal to the molded bifurcation.The breach was contained to a 0.5mm x 0.5mm area.A portion of the material around the hole appeared to be rounded and pointed inward.Greater damage was observed on the external surface of the tubing than on the inner lumen wall, which indicates that the hole was most likely created from an external source.A lot history review (lhr) of recv2497 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc was found leaking when doing flush test, a leak was from the base of catheter near the suture wing.No patient injury reported.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUIDE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8802289
• Report Number: 3006260740-2019-02008
• Device Sequence Number: 10877111
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 3275135
• Device Lot Number: RECV2497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1