MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXIMAL; 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
Event or Problem Description
It was reported that there is a leak at the hub of the catheter after placement.No other information was provided.
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 leaking in the catheter is confirmed but the exact cause is unknown.One 4 fr sl powerpicc catheter was returned for investigation.Use residue was observed throughout the sample.The catheter was split at the 19 cm depth marker.The proximal end of the catheter was flushed with water using a 12 ml syringe and was observed to leak at the hub/extension leg interface.Microscopic observation of the leak location at the hub revealed the catheter tubing to be split approximately halfway through the tubing.The break surface of the split was observed to be rough and granular.Based on the condition of the returned sample, possible contributing factors include material fatigue and excessive manipulation of the extension leg.Since a partial split in the extension tubing was present, the complaint is confirmed but the exact cause remains unknown.A lot history review was conducted for lot #recp2531 and revealed no similar incidents.
Event or Problem Description
It was reported that there is a leak at the hub of the catheter after placement.No other information was provided.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXIMAL
• 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: 8181896
• Report Number: 3006260740-2018-03621
• Device Sequence Number: 1437424
• Product Code: LJS
• UDI-Device Identifier: 00801741101441
• UDI-Public: (01)00801741101441
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: CK000424
• Device Lot Number: RECP2531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1