MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
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, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a knotted picc is confirmed and appears to be related to the use of the device.One dl powerpicc catheter segment was returned for investigation with a product label containing ref: ck000525a and lot: recz0553.Use residue was present throughout the sample.The catheter length extended from approximately the 31 cm depth marker to the 43 cm depth marker.The catheter hub and extension legs were not returned.A knot in the catheter was present between the 40 and 41 cm depth marker.The catheter wall thickness was measured at the 31 cm depth marker and was found to be within specification.Based on the condition of the returned sample, the catheter was likely knotted during use due to repeated advancement and retraction against resistance.Kinking of the catheter during insertion may have also contributed to formation of the knot.The product ifu states, "avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort" and "avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen." a lot history review (lhr) of recz0553 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc line knotted and difficult to remove.Removed without any patient harm.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8848313
• Report Number: 3006260740-2019-02233
• Device Sequence Number: 2088790
• Product Code: LJS
• UDI-Device Identifier: 00801741124075
• UDI-Public: (01)00801741124075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/31/2019

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: CK000525A
• Device Lot Number: RECZ0553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1