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

Model Number	3275335F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
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 be evaluated.Results are expected soon.A lot history review (lhr) of rebu1327 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc began to leak at the hub on the red extension after several months.The catheter was removed and replaced.
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 of a leak is confirmed; however the exact cause is unknown.One 5 fr dual lumen powerpicc ft was returned for evaluation.An initial visual observation showed use residue within the sample and some slight discoloration of the outer surface of the catheter.A split was observed in the extension leg tubing of the red lumen, just within the distal end of the luer connector.A microscopic observation revealed the fracture surface of the split was rough and exhibited cracks/fissures and beach marks, which are typical of material fatigue; however the exact cause of the split is unknown at this time.A lot history review (lhr) of rebu1327 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc began to leak at the hub on the red extension after several months.The catheter was removed and replaced.

• Brand Name: POWERPICC FT CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM NITINOL GUIDEW
• 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: 7602268
• Report Number: 3006260740-2018-01373
• Device Sequence Number: 1759633
• Product Code: LJS
• UDI-Device Identifier: 00801741027956
• UDI-Public: (01)00801741027956
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 3275335F
• Device Catalogue Number: 3275335F
• Device Lot Number: REBU1327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1