MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F SL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 is unconfirmed since the problem could not be reproduced during functional testing.One 4 fr powerpicc sl catheter was returned for investigation.An extension set was attached to the luer connector.The catheter extended up to the 46 cm depth marker.Evidence of use was present throughout the sample.Microscopic observation of the catheter surface did not reveal any apparent damage or leaks.The sample was flushed with water using a 12 ml syringe and was found to be patent to infusion.The distal end of the sample was clamped in order to pressurize the catheter.No leaks were observed.Since no apparent damage was observed during functional testing of the device, the complaint could not be confirmed.A lot history review (lhr) of recs1952 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc was found consistently leaking infusate at site, noted from day one and home health nurses had to do prn dressing changes all the time.Cxr was done and it was positioned in lower svc.The line was pulled and a new line placed in the opposite arm.No patient harm reported.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT
• 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: 9285487
• Report Number: 3006260740-2019-03457
• Device Sequence Number: 2310828
• Product Code: LJS
• UDI-Device Identifier: 00801741154737
• UDI-Public: (01)00801741154737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 1174108D1
• Device Lot Number: RECS1952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1